Reduction In Central Retinal Thickness Research Articles

Repeated Dexamethasone Intravitreal Implant for the Treatment of Diabetic Macular Oedema Unresponsive to Anti-VEGF Therapy: Outcome and Predictive SD-OCT Features

Purpose: To investigate dexamethasone intravitreal implant 0.7 mg (DEX implant) for the treatment of diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) therapy and evaluate predictive factors. Methods: Two-centre retrospective interventional case series, including 40 eyes of 31 patients treated with DEX implant for at least 2 consecutive cycles. Results: Mean ± SD intervals from implantation to recurrence in the first (4.2 ± 1.0 months) and second cycles (4.0 ± 0.9 months) were not significantly different. Best corrected visual acuity improved significantly (p < 0.001) by 7.0 ± 8.4 letters from baseline to month 2, and by 5.1 ± 6.9 letters between the first and second cycles. Central retinal thickness reduction 2 months after implantation was greater after the first (–194 ± 172 µm) than the second cycle (–134 ± 150 µm). Ellipsoid zone-external limiting membrane (EZ-ELM) disruption score decreased from 1.39 ± 1.16 at baseline to 1.24 ± 1.16 (p = 0.0832) after cycle 1 and remained stable 2 months after cycle 2. Eyes with persisting severe EZ-ELM disruption (score >2, n = 10) 2 months after the first DEX implant showed significantly (p = 0.0153) smaller visual acuity (VA) gains than eyes with less severe (score ≤2) EZ-ELM disruption. Conclusion: Repeated intravitreal DEX injections with average intervals of 4 months are valuable in patients with DME refractory to anti-VEGF therapy. Disorganization of outer retinal layers (EZ-ELM) may predict smaller VA gains if evaluated after initial reduction of macular oedema.

Spectral-Domain Optical Coherence Tomography-Driven Treat-and-Extend and Pro Re Nata Regimen in Patients with Macular Oedema due to Retinal Vein Occlusion: 24-Month Evaluation and Outcome Predictors

Purpose: To analyse the efficacy and outcome predictors of ranibizumab using a spectral-domain optical coherence tomography (SD-OCT)-driven treat-and-extend regimen (TER) versus SD-OCT-driven pro re nata regimen (PRN) in patients with cystoid macular oedema (CME) due to branch or central retinal vein occlusion (BRVO, CRVO). Methods: Retrospective, consecutive case series. Evaluation included best corrected visual acuity (BCVA), morphological parameters on SD-OCT, and treatment frequency. Results: From baseline to months 12, 18, and 24, BCVA improved by 16.6 ± 13.1, 15.5 ± 14.4, and 16.6 ± 15.8 letters, respectively, in TER (n = 45), compared to 11.3 ± 17.0, 11.0 ± 15.0, and 10 ± 20.5 letters in PRN (n = 31) (p = 0.152, p = 0.237, p = 0.172). The mean reduction in central retinal thickness was –261 ± 189, –272 ± 188, and –264 ± 158 μm, respectively, in TER, compared to –130 ± 196, –140 ± 210, and –166 ± 207 μm in PRN (p = 0.006, p = 0.017, p = 0.064). 59% (53%) of TER and 22% (17%) of PRN patients showed no intra- or subretinal fluid on SD-OCT at 12 (24) months. Using TER, the maximum recurrence-free treatment interval increased from 8.9 ± 2.3 weeks at 12 months to 9.8 ± 2.3 and 10.5 ± 2.7 weeks at 18 and 24 months, respectively. The number of injections was significantly higher in the TER than in the PRN group. Conclusions: In CME, due to BRVO/CRVO, TER provides better morphological outcome using more injections than PRN.

Low frequency ranibizumab versus dexamethasone implant for macular oedema secondary to branch retinal vein occlusion

BackgroundThe aim was to make a real‐world comparison of the efficacy of ranibizumab, dexamethasone and grid laser treatments in macular oedema due to branch retinal vein occlusion (BRVO).MethodsForty‐four eyes of 44 consecutive patients with macular oedema secondary to BRVO were included. Treatment arms comprised standard care (StCARE, n = 15), intravitreal ranibizumab (RNB, n = 14) and dexamethasone implant (DEX, n = 15). No rescue laser was performed in DEX and RNB groups. Main outcome measures were mean change in visual acuity (VA) and the percentage of patients who gained 10 or more letters from baseline to six months and central retinal thickness (CRT).ResultsImprovements in mean logMAR VA (p = 0.642) and letter score from baseline to month 6 were not statistically significantly different in all three groups. Mean follow‐up was 13.9 ± 10.7 months in RNB, 11.9 ± 6.3 in DEX and 11.4 ± 6.6 in StCARE. Mean number of injections was 2.4 ± 1.4 (range: 1–6) in RNB and 1.9 ± 0.7 (range: 1–3) in DEX group over the follow‐up period. Mean letter gain was 13.5 in DEX (p = 0.067), 7.1 in RNB (p = 0.553) and 4.5 in StCARE (p = 0.362). Mean CRT at baseline was 512.8 μm in DEX, 505.1 μm in RNB and 345.5 μm in the StCARE group. At the last visit, RNB provided the maximum reduction in CRT. Mean CRT decrease was −146.5 μm (28.6 per cent) in DEX, −241.3 μm (47.8 per cent) in RNB and −45.6 μm (13.2 per cent) in StCARE (p = 0.030). A statistically significant intraocular pressure elevation occurred in the DEX group (p = 0.005).ConclusionBoth RNB and DEX provided a significant resolution in macular oedema. Low frequency injections limited the visual gain in ranibizumab therapy. Visual results could be better with higher frequency injections and early start of treatment. Dexamethasone implants may be preferable in terms of visual improvement under low frequency injection conditions. Close follow‐up is mandatory for detection of intraocular pressure elevations. Laser monotherapy is not a reasonable first‐line option in the era of injection therapies.

EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT AND RANIBIZUMAB IN ASIAN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Subgroup Analyses From the VIEW Trials.

To assess the treatment effect of intravitreal aflibercept and ranibizumab in Asian patients with neovascular age-related macular degeneration. We evaluated data from VIEW 1 and VIEW 2, comparing functional and morphologic outcomes at Week 96 between intravitreal aflibercept 2 mg monthly (2q4) or 2 mg bimonthly after 3 initial monthly doses (2q8) versus ranibizumab 0.5 mg monthly among Asian patients (n = 269) and between Asian and white patients (n = 2044). In Asian patients, there were no significant differences between intravitreal aflibercept 2q4 and 2q8 compared with ranibizumab in mean gain in best-corrected visual acuity (10.23 and 8.35 vs. 8.51 letters). Reduction in central retinal thickness was greater for intravitreal aflibercept 2q4 (150.43 μm, P = 0.0075) and 2q8 (148.15 μm, P = 0.0126) than ranibizumab (119.46 μm). The proportion of dry retinas was greater for intravitreal aflibercept 2q4 (65.7%, P < 0.01) than ranibizumab (41.7%). There were no differences in outcomes between Asian and white patients. Serious treatment-emergent ocular adverse events occurred in <8% of treated eyes, evenly distributed across subgroups. In Asian patients with neovascular age-related macular degeneration, functional and morphologic outcomes were largely similar between intravitreal aflibercept and ranibizumab groups, and to results seen in white patients.

Polypoidal choroidal vasculopathy treatment options: A meta-analysis.

BackgroundCombined treatment with intravitreal anti‐vascular endothelial growth factor (anti‐VEGF) and verteporfin photodynamic therapy (PDT) is widely used for patients with polypoidal choroidal vasculopathy (PCV), although clinical evidence regarding the therapeutic efficacy and safety of such treatment remains lacking.Design/MethodsWe performed a meta‐analysis of previously reported studies comparing combination treatment, PDT monotherapy, and anti‐VEGF monotherapy. Primary outcome measures included changes in best‐corrected visual acuity (BCVA) and central retinal thickness (CRT). The proportion of patients with polyp regression was regarded as the secondary outcome measure.ResultsTwenty studies (three RCTs and 19 retrospective studies) involving 1,178 patients with PCV were selected. Significant differences in the proportion of patients with polyps were observed between the PDT and anti‐VEGF monotherapy groups at 3 and ≥6 months (P < .00001; and P = .0001, respectively). Significantly greater reductions in CRT were observed in the anti‐VEGF than in the PDT group at the 3‐month follow‐up (P = .04). Significantly greater improvements in BCVA were observed in the combined therapy group than in the PDT monotherapy group at 3, 6, 12, and 24 months (P = .03; P = .005; P = .02; and P < .00001, respectively). Combined treatment also resulted in significantly greater improvements in BCVA than monotherapy with anti‐VEGF at 6 and 24 months (P = .001; P < .00001, respectively), and significantly greater polyp regression than that observed following anti‐VEGF treatment at 3 and ≥6 months (P < .00001; P < .0001, respectively).ConclusionsCombined therapy involving anti‐VEGF agents and PDT may be more effective in improving long‐term outcomes for patients with PCV than monotherapy.

Dexamethasone implants in paediatric patients with noninfectious intermediate or posterior uveitis: first prospective exploratory case series

BackgroundTo evaluate the efficacy and safety of dexamethasone (DEX) implants in paediatric patients with noninfectious intermediate or posterior uveitis.MethodsProspective single center exploratory case series. Children and adolescents, 6 to 17 years old, with a vitreous haze score of ≥1.5+ or cystoid macular edema (CME) of >300 μm were enrolled. Vitreous haze score at month 2 was chosen as primary endpoint. Best corrected visual acuity (BCVA), central retinal thickness (CRT) and concomitant medication at month 6 were defined as secondary endpoints. Intraocular pressure (IOP) and cataract formation were determined as safety endpoints.ResultsThree out of 6 eligible patients participated in the case series. At month 2, vitreous haze was reduced from a score of 1.5+ to 0.5+ and 0 and BCVA improved by ≥3 lines, ≥4 lines and ≥2 lines of Early Treatment of Diabetic Retinopathy (ETDRS)-letters, respectively. Visual acuity gain was accompanied by a CRT reduction of −186 μm and −83 μm in the first and third patient, in whom CME was the indication for DEX implantation. A reduction of concomitant medication was achieved in 1 patient. IOP increase was seen in all 3 patients, but could be treated sufficiently with primarily IOP lowering medications and without need for glaucoma surgery. Cataract progression did not occur.ConclusionsDEX implants led to an improvement in all endpoints, especially BCVA. This study confirms that IOP rises may also occur in the paediatric population and should be monitored and treated appropriately.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials (EudraCT)- nr: 2013–000541-39.

Association between Y402H, E318D and R102G polymorphisms of complement proteins genes and the response to intravitreal anti-VEGF treatment in patients with neovascular age-related macular degeneration.

To analyze the correlation between the E318D rs9332739 polymorphism of the C2 complement factor; R102G rs2230199 polymorphism of the C3 complement factor as well as the Y402H rs1061170 polymorphism of the CFH complement factor andrisk of AMD as well as the response to anti-VEGF therapy. 106 patients with age-related macular degeneration treated with intravitreal ranibizumab or bevacizumab were enrolled. The response to treatment was assessed at 4 weeks intervals for 6 months and was based on the results of best corrected visual acuity and central retinal thickness measurements compared to the respective baseline values. Thecontrol group consisted of 58 healthy volunteers. The testing was performed using genetic probes (TaqMan Applied Biosystems) in all cases E318D (C2) and R102G (C3) polymorphisms were not associated with age-related macular degeneration. The genotype CC of Y402H (CFH) polymorphism was more frequent in patients with age-related macular degeneration as compared to controls [OR=3.09 (1.28–7.49); p=0.0069]. At the last follow-up, patients with age-related macular degeneration positive for the CC rs1061170 CFH genotype presented with worse best corrected visual acuity and increased central retinal thickness as compared to their counterparts negative for this genotype [OR=7.67 (1.77–33.12), p=0.0052]. Among 25.47% of “non-responders”, the CC rs1061170 CFH genotype was present in 51.8% of cases. In patients with the TT rs1061170 CFH genotype the final best corrected visual acuity was better and a significant reduction of central retinal thickness was demonstrated in all those cases, as compared to subjects with the CC rs1061170 CFH genotype [OR=0.31 (0.11-0.84), p=0.0194]. The study showed that the CC rs1061170 CFH genotype may be associated with the age-related macular degeneration. Additionally, the CC rs1061170 CFH genotype may promote a negative response to anti-VEGF treatment, while patients with the TT rs1061170 CFH genotype showed better functional and structural response to anti-VEGF agents.

Real-life clinical data for dexamethasone and ranibizumab in the treatment of branch or central retinal vein occlusion over a period of six months.

To evaluate the therapeutic outcome for dexamethasone implant (DEX) or intravitreal ranibizumab (IVR) injections over 6months in patients with macular edema due to branch or central retinal vein occlusion (BRVO, CRVO), in a real-life setting. A total of 107 patients with BRVO or CRVO were included into this retrospective single-center observational study. Patients were treated with monotherapy consisting of DEX or three monthly IVR injections following a pro re nata regimen (PRN). Best-corrected visual acuity (BCVA), central retinal thickness (CRT) and intraocular pressure (IOP) were compared between the two therapy groups after 1, 3 and 6months. BRVO patients treated with DEX achieved a statistically significant gain in BCVA measured in logMAR after 1month (mean gain, 95% CI: 0.21, 0.08-0.34, p = 0.001), 3months (0.16, 0.03-0.28, p = 0.012) and 6months (0.19, 0.07-0.32, p = 0.002), whereas patients treated with IVR showed a statistically significant BCVA gain in month 3 (mean improvement, 95% CI: 0.13, 0.01-0.26, p = 0.039) and month 6 (0.16, 0.03-0.29, p = 0.018). BCVA in CRVO patients with DEX worsened slightly at month 6 (mean worsening, 95% CI: -0.08, -0.24 to 0.08, p = 0.305), while IVR treated-patients achieved a statistically significant BCVA gain at 3months (mean improvement, 95% CI: 0.14, 0.02-0.25, p = 0.021). Both therapies were accompanied by statistically significant CRT reductions of 150 to 200μm (median). Adverse events reported were predictable and limited. In a clinical setting, comparable improvement in BCVA and CRT were observed after DEX and IVR injections for treatment of BRVO. CRVO patients showed greater benefit with IVR.

Multicenter, Randomized Clinical Trial to Assess the Effectiveness of Intravitreal Injections of Bevacizumab, Triamcinolone, or Their Combination in the Treatment of Diabetic Macular Edema.

To evaluate the efficacy of combined bevacizumab-triamcinolone intravitreal injection in the treatment of diabetic macular edema (DME) compared to monotherapy. At eight clinical sites, 111 patients with DME were randomly assigned to receive an intravitreal injection of bevacizumab (Avastin; Genentech, South San Francisco, CA), triamcinolone (Ophthalmos Pharmaceutical Industry, São Paulo-SP, Brazil), or their combination. The primary outcome was visual acuity (VA) at 6 months' follow-up. The average number of injections was 3.2 in the bevacizumab group, 2.4 in the combined group, and 2.1 in the triamcinolone group. All groups presented with improvements in VA (P < .001); however, no differences between groups were observed (P = .436). Mean reduction in central retinal thickness was statistically different only between the triamcinolone and bevacizumab groups (P < .015). Mono- or combination therapy was effective for DME treatment. No synergistic effects were observed; however, triamcinolone alone or a drug combination may reduce the number of injections required when compared to bevacizumab alone. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:734-740.].

The impact of epiretinal membrane on neovascular age‐related macular degeneration treatment: A spectral‐domain optical coherence tomography study

PurposeThe purpose of this prospective study was to evaluate the impact of epiretinal membrane (ERM) on anatomical and functional results in patients with wet age‐related macular degeneration (AMD) treated with intravitreal anti‐vascular endothelial growth (anti‐VEGF) injections.MethodsParticipants in the study were 48 patients with either wet AMD alone (n = 27) or AMD and ERM (n = 21). All patients received intravitreal anti‐VEGF injections (3 monthly injections and PRN thereafter) and were followed‐up for at least 12 months. All participants had best corrected visual acuity (BCVA) measurement and optical coherence tomography (OCT) at each visit, while fluorescein angiography was performed at baseline and then at the discretion of the physician. The main outcomes were the change in BCVA and central retinal thickness (CRT) along with the presence of fluid in the two groups.ResultsThere was a statistically significant improvement in BCVA in both groups, while the two groups did not differ significantly regarding BCVA at the end of the follow‐up. Accordingly, there was a statistically significant reduction in CRT in both groups, which did not have any difference in between. Patients with AMD alone presented subretinal fluid in a lower percentage than patients with AMD/ERM at the end of the follow‐up. In addition, patients with coexistence of AMD and ERM needed more injections than patients with AMD alone.ConclusionsPatients with AMD combined with ERM seemed to need more injections for the treatment of AMD, while they presented higher percentage of subretinal fluid at the 12‐month follow‐up, although there was no significant difference in BCVA and CRT in comparison with patients having AMD alone.

Comparison of 12-month therapeutic effect of conbercept and ranibizumab for diabetic macular edema: a real-life clinical practice study

BackgroundTo compare the efficacy of intravitreal conbercept and ranibizumab in the treatment of diabetic macular edema (DME) in a real-life clinical practice.MethodsThis was a retrospective study. Among 62 Chinese patients with DME, 32 patients (36 eyes) received intravitreal conbercept (IVC) injections and 30 patients (32 eyes) received intravitreal ranibizumab (IVR) injections, once a month for 3 months followed by as needed therapy. All participants had at least 12 months of follow-up. We compared the changes in best-corrected visual acuity (BCVA) letter score and central retinal thickness (CRT) between groups, as well as the number of intravitreal injections delivered. Safety was assessed with the incidence of adverse events (AEs).ResultsAt month 12, the mean BCVA letter score improved by 9.3 ± 5.2 with conbercept, and by 8.9 ± 4.4 with ranibizumab, the mean CRT reduction was 138.4 ± 97.7 μm and 145.2 ± 72.5 μm, respectively. There was no statistically significant difference of improvement in BCVA (P = 0.756) and decrease in CRT (P = 0.748) between the two groups. The number of intravitreal injections delivered was significantly higher (P = 0.027) in the IVR group (7.2 ± 1.0 per eye) than in the IVC group (6.6 ± 0.9 per eye). There were no severe ocular adverse reactions or systemic adverse events.ConclusionsBoth conbercept and ranibizumab are effective in the treatment of DME, achieving the similar clinical efficacy. In comparison to ranibizumab, conbercept shows a longer treatment interval and fewer intravitreal conbercept injections are needed.

Integrated results from the COPERNICUS and GALILEO studies.

ObjectivesTo report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO.Patients and methodsPatients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52.ResultsAt week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients.ConclusionThis analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO.

Intravitreal Aflibercept Versus Photodynamic Therapy in Chinese Patients with Neovascular Age-Related Macular Degeneration: Outcomes of the SIGHT Study

Purpose: SIGHT compared intravitreal aflibercept injections (IAI) with photodynamic therapy (PDT) in Chinese patients with predominantly classic choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD).Methods: Patients were randomized 3:1 to IAI (2 mg every 8 weeks after 3 initial monthly injections)/sham PDT or active PDT/sham IAI (with switch to IAI at week 28). We report the primary outcome (mean change in best-corrected visual acuity [BCVA] at week 28) and final 52-week outcomes.Results: Patients were randomized to IAI (n = 228) or PDT (n = 76) (mean age: 65.1 years). Mean BCVA change was +14.0 (IAI) versus +3.9 letters (PDT→IAI) (week 28) and +15.2 versus +8.9 letters (between-group difference: 6.2 letters; P = 0.0009) (week 52); mean reduction in central retinal thickness was −189.6 versus −170.0 μm (week 52). The greatest improvements in BCVA with IAI were in youngest patients (<65 years), and in those with a smaller active component of the CNV lesion (<50% of lesion size). The most common ocular treatment-emergent adverse events (study eye; IAI vs. PDT→IAI) were macular fibrosis (11.8% vs. 6.6%) and visual acuity reduced (6.6% vs. 21.1%). Three treatment-emergent Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were observed but none was considered drug related.Conclusions: IAI demonstrated superiority over PDT in Chinese nAMD patients. The benefits of IAI were maintained through week 52 in all patients, including subgroups, and in patients who switched from PDT to IAI. The incidence of adverse events was consistent with the known safety profile of IAI. Trial registration number NCT01482910.

Poprawa efektu leczenia wysiękowej postaci zwyrodnienia plamki żółtej związanego z wiekiem po zmianie terapii afliberceptem na leczenie ranibizumabem

The aim of the study: To evaluate anatomic and functional effects as well as the individual susceptibility to ranibizumab therapy in the absence of beneficial effects of aflibercept treatment in age-related macular degeneration. Material and Method: Ten patients, unsuccessfully treated with intravitreal aflibercept injections, were qualified for the ranibizumab injection program in AMD treatment. Ineffective treatment was understood as an increase in macular edema, and the resultant increase in central retinal thickness, and increased leakage in fluorescein angiography with an accompanying decrease in visual acuity and progression of changes on the Amsler grid. Following the treatment with ranibizumab injections, the above mentioned parameters were subject to further control. Results: Three patients experienced a reduction in central retinal thickness, edema and leakage area in fluorescein angiography, accompanied by reduced metamorphosis on the Amsler grid and stabilization or improvement of the best corrected visual acuity. Conclusion: The conversion of aflibercept therapy to ranibizumab therapy may be valuable for patients with no effective treatment with aflibercept. The problem requires further follow-up and assessment. Final conclusions might help design better methods for individual patient selection.

Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis.

Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis.

Two-year functional and anatomical results after converting treatment resistant eyes with exudative age-related macular degeneration to aflibercept in accordance with a treat and extend protocol.

To study the effects of converting to aflibercept in accordance with a treat and extend (T&E) strategy in eyes with treatment resistant exudative age-related macular degeneration (AMD). Two-year prospective study of eyes with exudative AMD and persistent macular fluid despite monthly treatment with ranibizumab or bevacizumab. Eyes were converted to 2.0mg aflibercept in accordance with a T&E protocol. Fifty eyes from 47 patients were included. At baseline, the mean central retinal thickness (CRT) was 273μm and mean best-corrected visual acuity (BCVA) 0.25 logarithm of the minimal angle of resolution (logMAR). The mean number of aflibercept injections the first year was 9.2. After 1year, there was a reduction in mean CRT to 228μm (p<0.001); 22 eyes (44%) had a dry macula; and the mean BCVA was 0.24 logMAR (p=0.531). The mean number of aflibercept injections the second year was 8.0 (p=0.013 compared to first year). After 2years, 24 eyes (48%) received treatment more frequently than every eighth week. The mean CRT was 225μm (p<0.001 compared to baseline); 31 eyes (62%) had a dry macula; and mean BCVA was 0.32 logMAR (p=0.005 compared to baseline). Five eyes did not complete 2years of aflibercept treatment after failing to improve. A majority of eyes showed improved anatomic outcomes. There was a small decrease in mean BCVA after the second year of treatment. About half of the eyes required treatment more frequently than the recommended aflibercept label of an 8-week interval.

PARS PLANA VITRECTOMY FOR DIABETIC MACULAR EDEMA: A Systematic Review, Meta-Analysis, and Synthesis of Safety Literature.

To assess the risk and benefit of pars plana vitrectomy for diabetic macular edema. The authors conducted a systematic literature review using PubMed, EMBASE, Web of Science, and Cochrane Central Database of Controlled Trials until September 2014. The population was patients with diabetic macular edema, intervention vitrectomy, comparator macular laser or observation, and efficacy outcome visual acuity and central retinal thickness. Safety outcomes were intraoperative and postoperative surgical complications. The efficacy meta-analysis included only randomized controlled trials. The safety analysis included prospective, retrospective, controlled, and uncontrolled studies. Five studies were eligible for the efficacy meta-analysis (n = 127 eyes) and 40 for the safety analysis (n = 1,562 eyes). Combining follow-up intervals from 6 to 12 months, the meta-analysis found a nonsignificant 2 letter visual acuity difference favoring vitrectomy, and a significant 102 μm greater reduction in central retinal thickness favoring vitrectomy, but a post hoc subgroup analysis found that a 6-month central retinal thickness benefit reversed by 12 months. The most frequent complications were retinal break (7.1%), elevated intraocular pressure (5.2%), epiretinal membrane (3.3%), and vitreous hemorrhage (2.4%). Cataract developed in 68.6% of 121 phakic eyes. Vitrectomy produces structural and functional improvements in select eyes with diabetic macular edema, but the visual gains are not significantly better than with laser or observation. No major safety concerns were identified.

24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting

BackgroundTo evaluate the clinical effectiveness and analyze the outcomes of a treat-and-extend (T&E) treatment regimen with ranibizumab for wet age-related macular degeneration (ARMD) in real life clinical settings over the first 2 years (24 months) of treatment.MethodsRetrospective analysis of visual acuity, spectral domain optical coherence tomography (SD-OCT) parameters and treatment burden data of 56 eyes of 54 unselected treatment naive patients diagnosed with exudative ARMD. Monthly injections were offered until no signs of disease activity such as intra-retinal (IRF) or sub-retinal fluid (SRF) were evident on SD-OCT, followed by a gradual extension of the treatment interval by 2 weeks until a maximum of 12 weeks.ResultsThe study met its main objective, demonstrating a mean best-corrected visual acuity gain of 8.3 letters (mean 68.8 ± 11) at month 12 and 5.2 letters (mean 65.7 ± 12.3) at 24 months compared to baseline (mean 60.5 ± 8.9). Anatomical improvement was also documented with a mean reduction of central retinal thickness by 139.7 μm at 24 months (244.9 ± 48.3) compared to baseline (384.6 ± 154.9). Forty-seven eyes (83.9% N = 56) gained vision or preserved baseline vision with 23 eyes (41.1%) gaining 10 letters or more at month 12. Out of the 46 eyes that completed 24 months of treatment and monitoring, 27 (58.7% N = 46) kept a BCVA above baseline with 18 of those (39% N = 46) maintaining a 10-letter gain throughout the 24 months. Six eyes (13% N = 46) lost more than 10 letters by month 24. The mean number of injections was 12.1 ± 2.8 over the 24-month period. Twenty-seven eyes (55.1% N = 56) achieved a treatment interval of 10 weeks or more at month 12, while the respective number at month 24 was 20 eyes (43.4% N = 46) in addition though to four more patients (8.7% N = 46) who were not receiving injections at month 24 since they were placed on a Monitor & Extend regime.ConclusionsThis is the first UK real-life study of a T&E treatment protocol with ranibizumab for exudative ARMD in a 24-month period and suggests that such a regimen is clinically effective and can achieve favourable outcomes with a significant reduction of the treatment burden compared to monthly PRN.

Effect of intravitreal aflibercept on recalcitrant diabetic macular edema

Background Despite anti-VEGF therapy, some patients develop chronic diabetic macular edema. The objective of this study was to evaluate anatomic and visual outcomes of switching patients with chronic DME from intravitreal bevacizumab or ranibizumab to intravitreal aflibercept injection.MethodsIn this retrospective observational case series, 11 eyes with recalcitrant diabetic macular edema (DME) were evaluated 6 months prior to and 6 months following initial intravitreal aflibercept injection (IAI). Recalcitrant DME was defined as having a thickened retina (≥350 μm) on spectral domain optical coherence tomography (SD-OCT) with persistent cystic changes (less than a 15% reduction in central retinal thickness) over 6 months prior to intravitreal aflibercept switch despite aggressive treatment for DME during this time.ResultsOne hundred and forty-seven patients in total were treated with IAI during this time, and of these, 31 patients were treated with IAI for DME. 18 eyes had less than 4 treatments within the 6 months prior to switch to IAI, 6 patients had a central retinal thickness (CRT) on SD-OCT of less than 350 μm at time of switch to IAI, and 2 patients had a greater than 15% decline in CRT on SD-OCT over the 6 months prior to switch to IAI. A total of 11 patients were included in the study. Over the 6 months prior to switch, the mean change in central retinal thickness was +18.6% and over the 6 months following switch to aflibercept the mean change in central retinal thickness was −27.1%. Switching to a regimen of at least 3 intravitreal aflibercept injections over 6 months resulted in some anatomic improvement and improvement or stabilization of Snellen visual acuity in all eligible patients.ConclusionsIn patients with recalcitrant diabetic macular edema, switching to intravitreal aflibercept resulted in improved a 25% or more decrease in central retinal thickness in 81% (9/11) patients at 6-month follow-up. Sixty-three percent (7/11) had improvement in Snellen visual acuity after switching to intravitreal aflibercept injection, suggesting some reversibility of functional damage.

Comparison of half-dose photodynamic therapy and 689 nm laser treatment in eyes with chronic central serous chorioretinopathy.

To compare visual and anatomical outcomes between half-dose photodynamic therapy (hd-PDT) and 689 nm laser therapy (689-LT) in chronic central serous chorioretinopathy (CSC). Forty eyes of 40 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive either hd-PDT or 689-LT delivering 95J/cm2 via an intensity application of 805mW/cm2 over 118s. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between the two treatment groups. Mean CSC duration was 17.1 ± 6.66weeks and 18.7 ± 7.46weeks in the hd-PDT and 689-LT groups respectively. Both groups showed significant BCVA improvements, as well as reductions in central retinal and subfoveal choroidal thickness. Although hd-PDT led to a faster reduction in central retinal thickness, no significant differences were recorded between groups for any other measured parameter at any time point. Complete photoreceptor recovery was observed in eight and seven eyes in the hd-PDT and 689-LT groups respectively. Both hd-PDT and 689-LT were effective at treating chronic CSC. Further studies are warranted to evaluate long-term safety and efficacy.