Ranibizumab Group Research Articles

Short-term choroidal thickness changes in patients treated with either ranibizumab or aflibercept: a comparative study

PurposeTo compare, in neovascular age-related macular degeneration (AMD) patients, short-term choroidal thickness changes in eyes treated using ranibizumab with those in eyes treated using aflibercept.MethodsThis retrospective, observational study included 240...

Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial

To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up andretreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P= 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P < 0.001; aflibercept vs. ranibizumab, P= 0.04; bevacizumab vs. ranibizumab, P= 0.01). At 2 years, mean VA improved by 12.8, 10.0, and 12.3 letters, respectively. Treatment group differences varied by baseline VA (P= 0.02 for interaction). With worse baseline VA (20/50 to 20/320), mean improvement was 18.1, 13.3, and 16.1 letters, respectively (aflibercept vs. bevacizumab, P= 0.02; aflibercept vs. ranibizumab, P= 0.18; ranibizumab vs. bevacizumab, P= 0.18). With better baseline VA (20/32 to 20/40), mean improvement was 7.8, 6.8, and 8.6 letters, respectively (P > 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P= 0.047; aflibercept vs. bevacizumab, P= 0.34; aflibercept vs. ranibizumab, P= 0.047; ranibizumab vs. bevacizumab, P= 0.20; global P= 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials.

Aflibercept for neovascular age-related macular degeneration.

Aflibercept for neovascular age-related macular degeneration.

Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema

To compare long-term vision and anatomic effects of ranibizumab with prompt or deferred laser vs laser or triamcinolone+ laser with very deferred ranibizumab in diabetic macular edema (DME). Randomized clinical trial. Eight hundred and twenty-eight study eyes (558 [67%] completed the 5-year visit), at 52 sites, with visual acuity 20/32 to 20/320 and DME involving the central macula were randomly assigned to intravitreous ranibizumab (0.5mg) with either (1) prompt or (2) deferred laser; (3) sham injection+ prompt laser; or (4) intravitreous triamcinolone (4mg)+ prompt laser. The latter 2 groups could initiate ranibizumab as early as 74weeks from baseline, for persistent DME with vision impairment. The main outcome measures were visual acuity, optical coherence central subfield thickness, and number of injections through 5 years. At 5 years mean (± standard deviation) change in Early Treatment Diabetic Retinopathy Study visual acuity letter scores from baseline in the ranibizumab+ deferred laser (N= 111), ranibizumab+ prompt laser (N= 124), laser/very deferred ranibizumab (N= 198), and triamcinolone+ laser/very deferred ranibizumab (N= 125) groups were 10 ± 13, 8 ± 13, 5 ± 14, and 7 ± 14, respectively. The difference (95% confidence interval) in mean change between ranibizumab+ deferred laser and laser/very deferred ranibizumab and triamcinolone+ laser/very deferred ranibizumab was 4.4 (1.2-7.6, P= .001) and 2.8 (-0.9 to 6.5, P= .067), respectively, at 5 years. Recognizing limitations of follow-up available at 5 years, eyes receiving initial ranibizumab therapy for center-involving DME likely have better long-term vision improvements than eyes managed with laser or triamcinolone+ laser followed by very deferred ranibizumab for persistent thickening and vision impairment.

Comparison of intravitreal aflibercept and ranibizumab injections on subfoveal and peripapillary choroidal thickness in eyes with neovascular age-related macular degeneration.

We aimed to compare changes in subfoveal and peripapillary choroidal thickness (CT) after intravitreal aflibercept or ranibizumab injections for neovascular age-related macular degeneration (AMD). Medical records of 54 treatment-naïve, consecutive patients (54 eyes) who were diagnosed with neovascular AMD and received three monthly injections of aflibercept (21 eyes) or ranibizumab (33 eyes) were reviewed. Subfoveal and peripapillary CT were measured with images obtained using spectral domain optical coherence tomography at baseline and at three months. Subfoveal CT decreased from 232.2 ± 94.4μm at baseline to 207.1 ± 89.3μm at three months in the aflibercept group (p < 0.001) and from 231.5 ± 102.9μm to 220.0 ± 98.0μm in the ranibizumab group (p = 0.006). The reduction was greater in the aflibercept group than in the ranibizumab group (p = 0.024). Peripapillary CT decreased from 157.2 ± 62.2μm at baseline to 147.4 ± 62.2μm at three months in the aflibercept group (p < 0.001). However, the change in peripapillary CT from 154.9 ± 46.5μm at baseline to 152.3 ± 50.0μm at three months was not significant in the ranibizumab group (p = 0.123). Intravitreally injected aflibercept significantly decreased subfoveal CT more than ranibizumab. Choroidal thinning after aflibercept injection was not limited to the subfoveal area, but extended beyond the macula as well.

Comparison of Short-Term Clinical Outcomes between Intravitreal Ranibizumab and Aflibercept in Retinal Angiomatous Proliferation

Purpose: To evaluate the 6-month outcomes of intravitreal ranibizumab and aflibercept treatment for patients with retinal angiomatous proliferation (RAP). Methods: A retrospective review of medical records of 28 patients (31 eyes) diagnosed with RAP was performed. All patients were initially treated with 3 consecutive intravitreal ranibizumab or aflibercept injections after diagnosis. Additional treatment was performed when exudation recurred. The best-corrected visual acuity (BCVA) and central foveal thickness were measured before the first injection and 3 and 6 months after the first injection. The values measured before the treatment were compared with those after treatment. Results: Sixteen eyes were treated with ranibizumab and 15 eyes with aflibercept. The logarithm of minimal angle of resolution (log MAR) values of BCVA before the first injection and 3 and 6 months after the first injection were 0.78 ± 0.50, 0.47 ± 0.30 and 0.59 ± 0.41 in the ranibizumab group and 0.96 ± 0.52, 0.83 ± 0.52 and 0.74 ± 0.56 in the aflibercept group, respectively. Central foveal thickness was 315.75 ± 115.44, 188.38 ± 57.33 and 218.50 ± 96.49 μm in the ranibizumab group and 249.00 ± 74.88, 143.73 ± 32.73 and 196.73 ± 94.08 μm in the aflibercept group, respectively. BCVA was significantly improved and central foveal thickness was significantly reduced at 6 months (p < 0.05) compared to measurements before the first injection in both groups. However, BCVA improvement and central foveal thickness were not significantly different between the 2 groups. Conclusions: Both intravitreal ranibizumab and aflibercept treatments were beneficial for both normalizing macular thickness and improving visual acuity in patients with RAP. The efficacy of the 2 drugs was not noticeably different. J Korean Ophthalmol Soc 2016;57(2):243-247

Is There Any Difference between Ranibizumab and Aflibercept Injections in Terms of Inflammation Measured with Anterior Chamber Flare Levels in Age-Related Macular Degeneration Patients: A Comparative Study

Purpose: To evaluate the inflammatory reaction to intravitreal aflibercept (IVA) or ranibizumab (IVR) in patients with age-related macular degeneration (AMD). Methods: A total of 60 eyes of 60 neovascular AMD patients and 30 eyes of 30 age-matched healthy people as a control group were included in this observational, prospective, comparative study. The AMD patients received 1:1 either IVA or IVR. Anterior chamber flare was measured with the Kowa FM-600 laser flare meter (Kowa Company, Ltd., Tokyo, Japan) at days 0, 1, and 30. The mean flare value and standard deviation are expressed as photon counts per millisecond. Results: There were 51 (56.7%) men and 39 (43.3%) women, with a mean age of 72.7 ± 7.5 years. Mean aqueous flare values at baseline, day 1 and day 30 were 7.08 ± 2.44, 7.23 ± 2.56, and 6.99 ± 2.29, respectively, for the IVR group, 6.87 ± 3.18, 6.86 ± 3.19, and 6.53 ± 2.79, respectively, for the IVA group, and 6.4 ± 3.29, 6.41 ± 3.06, and 6.42 ± 3.05, respectively, for the control group. There was no statistically significant difference in terms of baseline flare values for these three groups (p = 0.666). At the 1-day follow-up, a slight but not significant increase in flare was observed in the ranibizumab group. However, there was no significant change in aqueous flare values in either the ranibizumab- or the aflibercept-injected patients (p = 0.768 and p = 0.387, respectively) or between the groups (p = 0.635). No significant clinical inflammatory reactions were noted before or after intravitreal injections of either ranibizumab or aflibercept. Conclusion: No significant short-term intraocular inflammation was noted in the eyes receiving aflibercept or ranibizumab for the treatment of neovascular AMD. Although aflibercept has more immunogenic properties than ranibizumab, such as having an extra Fc portion and being a larger molecule, it is likely that its more potent anti-inflammatory effects prevent it from inducing inflammation.

Long-term outcomes of combination photodynamic therapy with ranibizumab or bevacizumab for treatment of wet age-related macular degeneration.

Aim:To evaluate and compare the efficacy of combination of ranibizumab or bevacizumab with photodynamic therapy (PDT) in treating choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD) on long-term follow-up.Materials and Methods:Of 42 eyes, 18 were treated with bevacizumab (Group A) and 24 with ranibizumab (Group B) in combination with verteporfin PDT. Treatment was initiated after informed consent. Complete ophthalmic examination including optical coherence tomography (OCT) was performed at presentation, 1 month, 3 months, and subsequent follow-up visits. OCT measures used were lesion thickness (LT) of the CNV, retinal thickness above the lesion (RT), and central macular thickness (CMT). Mean follow-up period was 33 months (median 18, range 1-84). Additional treatment on follow-up was left at treating surgeon's discretion.Results:Visual acuity improved significantly from baseline by 0.3 LogMAR in Group A and 0.26 LogMAR in Group B. LT decreased significantly from 1st month onward and remained significant at all the subsequent visits, in both the groups. CMT and RT showed a decreasing trend in both the groups. No difference was seen in visual acuity (VA), LT, CMT, and RT between Group A and Group B at any of the visits. The mean number of additional anti-vascular endothelial growth factor injections given postcombination therapy were 1.5 (median 1, range 0-7) injections per eye.Conclusions:PDT in combination with either ranibizumab or bevacizumab was equally effective in preventing vision loss in eyes with wet-Age-related macular degeneration (ARMD). Such combination also reduces the economic burden of the treatment.

Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.

Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME). To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy. Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015. Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n = 203 eyes), or ranibizumab, 0.5 mg, by intravitreous injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n = 191 eyes). Eyes in both treatment groups could receive ranibizumab for DME. The primary outcome was mean visual acuity change at 2 years (5-letter noninferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization. Mean visual acuity letter improvement at 2 years was +2.8 in the ranibizumab group vs +0.2 in the PRP group (difference, +2.2; 95% CI, -0.5 to +5.0; P < .001 for noninferiority). The mean treatment group difference in visual acuity area under the curve over 2 years was +4.2 (95% CI, +3.0 to +5.4; P < .001). Mean peripheral visual field sensitivity loss was worse (-23 dB vs -422 dB; difference, 372 dB; 95% CI, 213-531 dB; P < .001), vitrectomy was more frequent (15% vs 4%; difference, 9%; 95% CI, 4%-15%; P < .001), and DME development was more frequent (28% vs 9%; difference, 19%; 95% CI, 10%-28%; P < .001) in the PRP group vs the ranibizumab group, respectively. Eyes without active or regressed neovascularization at 2 years were not significantly different (35% in the ranibizumab group vs 30% in the PRP group; difference, 3%; 95% CI, -7% to 12%; P = .58). One eye in the ranibizumab group developed endophthalmitis. No significant differences between groups in rates of major cardiovascular events were identified. Among eyes with proliferative diabetic retinopathy, treatment with ranibizumab resulted in visual acuity that was noninferior to (not worse than) PRP treatment at 2 years. Although longer-term follow-up is needed, ranibizumab may be a reasonable treatment alternative, at least through 2 years, for patients with proliferative diabetic retinopathy. clinicaltrials.gov Identifier: NCT01489189.

Anti-VEGF Pharmacotherapy as an Alternative to Panretinal Laser Photocoagulation for Proliferative Diabetic Retinopathy

From 1976 to 1981, the results of the Diabetic Retinopathy Study identified that panretinal laser photocoagulation (PRP) for high-risk proliferative diabetic retinopathy (PDR) reduced the rate of severe visual acuity loss by more than 50% compared with the natural history of the disease. 1,2 The Diabetic Retinopathy Study identified 4 key risk features of PDR (retinal neovascularization [NV]; NV within 1 disc diameter of the optic disc [NVD]; severe NV [NVD >¼ to ⅓ disc diameters or NV elsewhere >½ disc diameter]; and preretinal or vitreous hemorrhage) and indicated that the presence of 3 or more risk factors constituted high-risk characteristics for developing severe vision loss. 3 The results of the Diabetic Retinopathy Study have served as the basis for the accepted standard of care in the management of PDR for decades. In this issue of JAMA, the investigators from the Diabetic Retinopathy Clinical Research Network (DRCR.net) present the results of a clinical trial comparing PRP and intravitreous ranibizumab among patients with PDR. 4 This noninferiority study included 305 adults with PDR, including 89 participants who had both eyes enrolled, for a total of 394 study eyes. Patients in the ranibizumab group (n = 191 eyes) received intravitreous ranibizumab (0.5 mg) (and PRP if treatment failed) and received ranibizumab as needed for diabetic macular edema, whereas patients in the PRP group (n = 203 eyes) re

Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study

Objective:To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.Methods:RESTORE comprises a phase 3, randomized, multicenter, 12 month core study and a 24 month open-label extension study. Eyes assigned to ranibizumab in the core study received ranibizumab for 36 months; eyes assigned to laser monotherapy in the core study received ranibizumab during the extension. The primary outcome was least-squares mean change in National Eye Institute 25-item Visual Functioning Questionnaire (NEI VFQ-25) overall composite and subscale scores.Results:Of 303 core study participants, 240 (79%) entered the extension, comprising 83 (35%) participants initially assigned to ranibizumab, 83 (35%) assigned to ranibizumab plus laser combination therapy, and 74 (31%) assigned to laser monotherapy. Least-squares mean (standard error) change in NEI VFQ-25 composite score from baseline to month 12 (+5.9 [1.5]; +5.0 [1.5], for the ranibizumab and combination therapy groups, respectively) decreased by month 36 (+4.1 [1.7]; +4.0 [1.7], respectively, from baseline to month 36) following reduced injection frequency relative to the core study. At 36 months, the least-squares mean (standard error) change in the laser monotherapy group was similar to that in the ranibizumab groups (+4.1 [1.8]). Most subscale scores showed outcomes similar to that for the composite score. The greatest NEI VFQ-25 gains were consistently observed in participants for whom the study eye was the better-seeing eye.Limitations:Patients entering the extension were not randomized, and 21% of the core study participants did not enter the extension, which may have affected the results.Conclusions:Gains in patient-reported visual function at month 12 among eyes receiving ranibizumab in the core study decreased slightly by 36 months. Eyes originally receiving laser monotherapy for 12 months then ranibizumab for 24 months achieved similar gains by 36 months to eyes receiving ranibizumab for 36 months.Trial Registration:ClinicalTrials.gov: NCT00687804 and NCT00906464.

Intra‐ocular pressure spike after Aflibercept and Ranibizumab intravitreal injections

PurposeSince anti‐VEGFsapproval, intra vitreous injections (IVI) represent a booming therapeutic delivery mode. Immediate ocular hypertension (OHT) induced is known after these IVIs. The purpose of this study is to compare the OHT after Aflibercept and Ranibizumab IVI.MethodsIn this prospective study, we compared 30 patients who received an Aflibercept IVI (0.05 mL) to 30 patients who received Ranibizumab for wet AMD. IVI were performed with a 30G needle pushed to the hilt with an anti‐reflux system. We measured intraocular pressure (IOP) using a portable aplanation tonometer PERKINS MK2 (Haag‐Streit, Koeniz, Switzerland) before injection (T0), immediately after IVI (T1), 5 minutes (T5), 15 minutes (T15) and 45 minutes (T45) after the IVI. IOP were compared by a t‐test.ResultsIn Aflibercept group, at T0, IOP was 13.4 mmHg+1.5. All patients had a significant increase in IOP at T1 (42.7 mmHg+3, p &lt; 0.001). At T5, IOP decreased but was still statistically higher than baseline IOP (23.6 mmHg+3.1, p &lt; 0.001). At T15, IOP returned to normal values but was higher than T0 (16.2mmHG + 2.1, p = 0.009). At T45, IOP was 13 mmHg + 1.2, with no significant difference from baseline (p = 0.65). In Ranibizumab group, baseline IOP was 13.8 mmHg + 1.1. IOP increased at T1 (45.6 mmHg + 2.2, p &lt; 0.001). At T5 and T15, IOP were still higher than baseline (24.6 mmHg + 2.2, p &lt; 0.001 and 17.9 + 1.5, p &lt; 0.001). At T45, IOP was 12.7 mmHg + 1.5, with no significant difference from baseline (p = 0.12). At each time measure, there is no statistically difference between two groups.ConclusionsAflibercept and Ranibizumab IVI induce an IOP spike for a short time. It seems to be equal between the two drugs and essentially related to the injected volume.

Prevention of ovarian hyperstimulation syndrome in a rat model: comparison of the efficacy of tocilizumab with that of ranibizumab, cabergoline, and a gonadotropin-releasing hormone antagonist

The aim of the study is to investigate the effects of the interleukin-6 (IL-6) blocker tocilizumab in a hyperstimulated rat model and compare it with ranibizumab, a gonadotropin-releasing hormone antagonist (GnRHA), and cabergoline. Forty-seven rats were randomly divided into the following seven groups: Group 1: OHS; Group 2: OHS+ GnRHA; Group 3: OHS + ranibizumab; Group 4: OHS + cabergoline; Group 5: OHS + low-dose tocilizumab (TL); Group 6: OHS + high-dose tocilizumab (TH); Group 7: sham. Ovarian weight was significantly lower only in the ranibizumab group than in the OHS group. Estrogen levels were significantly lower in the GnRHA group than in the OHS and the treatment groups. Progesterone levels were significantly lower in the ranibizumab, cabergoline, and TL groups than in the OHS group. Among the treatment groups, corpus luteum counts were lower than in the OHS group. Corpus luteum counts were lowest in the tocilizumab groups. IL-6 intensity was lower in all treatment groups than in the OHS group. In the ranibizumab group IL-6 intensity was the lowest. The TL group did not significantly differ from the GnRHA and cabergoline groups regarding IL-6 expression. Ovarian VEGF expression was significantly lower in all treatment groups. For the TL, ranibizumab, and cabergoline groups VEGF intensity was similar. Tocilizumab may be a new strategy for preventing ovarian hyperstimulation syndrome by inhibition of IL-6.

Feasibility and efficacy of a mass switch from ranibizumab (Lucentis) to bevacizumab (Avastin) for treatment of neovascular age-related macular degeneration.

To assess the feasibility and potential obstacles of a departmental switch from ranibizumab (Lucentis, Genentech, South San Francisco, CA) to bevacizumab (Avastin, Genentech) for the treatment of neovascular age-related macular degeneration (AMD). A total of 154 eyes treated for wet AMD with ranibizumab or bevacizumab were examined over a 10-month period. The treatment protocol was monthly induction therapy followed by injections as needed for macular edema or subretinal fluid on optical coherence tomography, new hemorrhage or edema on examination, worsening vision, or leakage on fluorescein angiography. Central subfield thickness and pinhole vision were the main treatment outcomes. Study windows were compared using t tests and Mann-Whitney U tests. Statistical significance was defined as a P value of <0.05. The majority of patients (88%) were willing to accept a bevacizumab injection. There was no difference in frequency of injection, central subfield thickness, visual outcome, or endophthalmitis rate between the ranibizumab and bevacizumab groups. A small subset of patients (4.5%) appeared to respond more favorably to ranibizumab than bevacizumab. Bevacizumab appears to be a cost-effective alternative to ranibizumab for the treatment of neovascular AMD. Patients previously treated with ranibizumab are typically willing to switch to bevacizumab. In the overwhelming majority of patients, there is no major decline in clinical status. However, select patients may respond better to ranibizumab injections.

Comparative analysis of the development of collateral vessels in macular edema due to branch retinal vein occlusion following grid laser or ranibizumab treatment.

PurposeTo evaluate the differences in the development of collateral vessels in patients with macular edema due to branch retinal vein occlusion (BRVO) after treatment with either grid laser or ranibizumab (RNB).MethodsComparative study including patients with macular edema due to acute BRVO and best-corrected visual acuity (BCVA) between 20/40 and 20/200. The sample was divided into two groups according to the treatment applied: laser group, including eyes treated with Argon laser when retinal hemorrhages were sufficiently absorbed to perform the treatment, and RNB group, including patients treated initially with one monthly intravitreal injection for a period of 3 months of RNB and more injections according to need thereafter. Before treatment patients in both groups, received a complete ophthalmic examination, including BCVA, fundus examination, optical coherence tomography, fundus color photography, and fundus fluorescein angiography (FA). This same protocol of examination was repeated in every visit after treatment, except FA that was only repeated every 3 months. The detection of the collateral vessels was done by two experienced examiners based on the analysis of the early phase of the FA. If there was a discrepancy in their judgment, the criterion of a third examiner evaluating the FA was considered.ResultsMean baseline BCVA was 0.86±0.26 and 0.82±0.25 (logMAR [logarithm of the minimum angle of resolution]) in the RNB and laser groups, respectively (P=0.83). At the end of the follow-up, mean BCVA was 0.38±0.18 and 0.64±0.33 (logMAR) in the RNB and laser groups, respectively. The difference in the final BCVA between both groups was statistically significant (P=0.002). Collaterals developed in both groups; 66.67% of patients (14 out of 21 patients) developed collaterals at a mean time of 6.14±2.60 months after diagnosis in the RNB group, and 68.18% (16 out of 22 patients) developed collaterals in the laser group at a mean time of 6.2±1.97 months after diagnosis. No statistically significant differences between groups were found in the number of cases developing collateral vessels (P=1.00) as well as in the time required for such development (P=0.947).ConclusionThe use of RNB for the treatment of macular edema due to BRVO does not seem to alter the development of collateral vessels. Future studies with larger samples are required to confirm these outcomes.

EFFECT OF PEGAPTANIB AND RANIBIZUMAB ON PLASMA AND VITREOUS HOMOCYSTEINE IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION.

To investigate homocysteine (Hcy) concentration in the blood plasma and the vitreous in patients with exudative age-related macular degeneration receiving intravitreal anti-vascular endothelial growth factor therapy. Plasma Hcy and vitreous Hcy levels were analyzed in 73 exudative age-related macular degeneration patients (50.7% received pegaptanib 0.3 mg and 50.3% received ranibizumab 0.5 mg) and compared with 80 controls and 40 patients with idiopathic epiretinal membranes, respectively. Homocysteine concentration was measured by immunonephelometric particle test, and it was determined before and after antiangiogenic therapy. The mean Hcy concentrations (± SD) of blood plasma and vitreous were 13.0 ± 4.2 μmol/L and 1.00 ± 0.3 μmol/L in patients treated with pegaptanib; in ranibizumab group, they were 12.8 ± 2.5 μmol/L and 1.4 ± 0.6 μmol/L, respectively. The results of plasma and vitreous Hcy indicated statistically significant differences between exudative age-related macular degeneration patients and control groups (P = 0.03 and P = 0.02). After 6 months with both intravitreal therapies, the plasma and vitreous Hcy concentrations did not change significantly (P = 0.1). Pegaptanib and ranibizumab did not increase the plasma or vitreous Hcy concentrations.

Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis.

AimsAge-related macular degeneration (AMD) is the main cause of blindness. Anti-vascular endothelial growth factor is used to prevent further neovascularization due to wet AMD. The purpose of this systematic review was to investigate the effect and protocol of anti-vascular endothelial growth factor treatment on wet AMD.MethodsA comprehensive literature search was performed in PubMed, Embase, the Cochrane Library, CNKI, and reference lists. Meta-analysis was performed using Stata12.0 software, best corrected visual acuity (BCVA), retinal thickness, and lesion size were evaluated.ResultsTwelve randomized controlled trials spanning from 2010 to 2014 and involving 5,225 patients were included. A significant difference was observed between the intravitreal ranibizumab (IVR) group and the intravitreal bevacizumab group (standard mean difference =−0.14, 95% confidence interval [CI] =−0.23 to −0.05). No significant differences were observed in best corrected VA, retinal thickness, or lesion size between IVR and the intravitreal aflibercept group. Compared to monthly injection, IVR as-needed injections (PRN) can raise VA by 1.97 letters (weighted mean difference =1.97, 95% CI =0.14–3.794). Combination therapy of IVR and photodynamic therapy can significantly raise VA by 2.74 letters when combined with IVR monotherapy (weighted mean difference =2.74, 95% CI =0.26–5.21).ConclusionThe superiority remains unclear between IVR and intravitreal bevacizumab in the treatment of neovascular AMD. Intravitreal aflibercept dosed every 2 months required fewer injection times, but produced similar efficacy as monthly IVR. IVR PRN could significantly increase VA. Combined with photodynamic therapy, IVR therapy could also increase VA effectively.

Choroidal Thickness Changes After Intravitreal Antivascular Endothelial Growth Factor Therapy for Age-Related Macular Degeneration: Ranibizumab Versus Aflibercept.

To compare the changes in subfoveal choroidal thickness (CT) in eyes with neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab or aflibercept. In this retrospective case series, the medical records of 28 patients with nAMD treated with at least 3 consecutive monthly injections of ranibizumab (0.5 mg/0.05 mL) or aflibercept (2 mg/0.05 mL) between December 2013 and June 2014 and who were followed up for at least 3 months were reviewed. Subfoveal choroidal thickness was measured using enhanced depth imaging optical coherence tomography. Choroidal thickness decreased over time in the aflibercept group, but was unchanged throughout the study in the ranibizumab group. At each time point, the decrease was significantly greater in aflibercept-treated eyes compared with ranibizumab-treated eyes (P<0.05). No significant change in best-corrected visual acuity (BCVA) was seen in either group during follow-up. There was no correlation between change in choroidal thickness and age, sex, duration of previous antivascular endothelial growth factor treatment, number of previous injections, spherical equivalent, baseline choroidal thickness, and the BCVA outcome in either group. Subfoveal choroidal thickness appeared to decrease significantly in eyes with nAMD during 3 months of aflibercept treatment. No corresponding decrease in choroidal thickness occurred in ranibizumab-treated eyes.

Efficacy/safety of ranibizumab monotherapy or with laser versus laser monotherapy in DME

ObjectiveTo compare the efficacy and safety of ranibizumab 0.5 mg intravitreal injection, as monotherapy or in combination with laser, with laser monotherapy in patients with visual impairment caused by diabetic macular edema. DesignTwelve-month, multicentre, open-label, parallel-group, randomized, active-control study. ParticipantsA total of 220 (ranibizumab monotherapy: n = 75, ranibizumab + laser: n = 73, laser monotherapy: n = 72) patients with a diagnosis of type I or II diabetes and visual impairment caused by macular edema were included in the efficacy analysis. MethodsRanibizumab was initiated with a fixed loading phase of 3 monthly injections followed by as needed therapy until stable vision achievement. Efficacy end points were the change in best corrected visual acuity (BCVA), change in central retinal thickness (CRT) measured by optical coherence tomography, proportion achieving a 15-letter BCVA gain, and 12-month Visual Function Questionnaire-25 (VFQ-25) score. Safety was assessed with the incidence and severity of adverse events. ResultsAt 12 months, significant (p < 0.001) mean BCVA improvements were observed for both the ranibizumab monotherapy (+8.9 [95% confidence interval (CI) 7.0–10.7] letters) and the ranibizumab + laser (+8.2 [95% CI 6.0–10.4] letters) groups compared with the laser monotherapy group (+0.3 [95% CI –2.9 to 3.5] letters). Similarly, a better response in terms of CRT improvement, BCVA letter gain, and VFQ-25 was observed in both ranibizumab groups compared with laser monotherapy. The safety profile was comparable in the 2 ranibizumab groups. ConclusionsRanibizumab as monotherapy or combined with laser resulted in significantly higher improvements in visual acuity and vision-related quality of life at month 12 as compared with laser monotherapy.

Intraocular Pressure in Patients with Neovascular Age-Related Macular Degeneration Receiving Intravitreal Aflibercept or Ranibizumab

To assess change in intraocular pressure (IOP) in patients with neovascular age-related macular degeneration (NVAMD) receiving intravitreal aflibercept injection (IAI) or ranibizumab in VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies. Analyses from 2 randomized, active-controlled, phase III trials. A total of 2457 patients with NVAMD. Patients received IAI 2 mg every (q) 4 weeks (2q4), 0.5 mg q4 weeks (0.5q4), 2 mg q8 weeks (after 3 monthly doses; 2q8), or ranibizumab 0.5 mg q4 weeks (Rq4) for 52 weeks. At week 52, patients were switched to a variable regimen requiring at least quarterly dosing and allowing interim injections based on anatomic and visual assessment. Pre-injection IOP was analyzed in study and uninjected fellow eyes from baseline to week 96. Prespecified end points included mean change in IOP from baseline and prevalence of a >21 mmHg and >10 mmHg increase in IOP from baseline. Cumulative incidence of sustained (at 2 consecutive visits) IOP >21 mmHg, a single event of IOP >25 mmHg, and sustained IOP increase from baseline (≥5 mmHg) was also evaluated. Mean IOP change from baseline over 96 weeks in all IAI groups was consistently lower than in the Rq4 group, and this finding was replicated in both trials. In an analysis integrating both studies, the proportion of study eyes with IOP >21 mmHg at week 96 was 20.2%, 14.2%, 12.1%, and 12.5% in Rq4, 2q4, 2q8, and 0.5q4, respectively. Reduction in risk, relative to Rq4, of having sustained IOP >21 mmHg over 96 weeks was 62% (95% confidence interval [CI], 36%-78%), 50% (95% CI, 19%-70%), and 69% (95% CI, 45%-84%) for 2q4, 2q8, and 0.5q4, respectively. Risk reduction in the IAI groups for a sustained IOP increase ≥5 mmHg was 31% (95% CI, 8%-48%), 38% (95% CI, 17%-54%), and 47% (95% CI, 27%-61%), respectively. In uninjected fellow eyes, only sustained IOP >21 mmHg events were higher in the Rq4 group compared with all IAI groups. Incidence of elevated IOP in eyes with NVAMD was lower in all IAI groups than in the ranibizumab group.