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      Ranibizumab Pretreatment in Vitrectomy with Internal Limiting Membrane Peeling on Diabetic Macular Edema in Severe Proliferative Diabetic Retinopathy

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          Abstract

          Aim

          To evaluate the efficacy of intravitreal ranibizumab (IVR) pretreatment for pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling in severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME).

          Methods

          Sixty-three patients with ME and PDR were divided into IVR and control groups. Three days before PPV stripping, ranibizumab was injected into the patients in the IVR group. The patients were followed for 6 months. The best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications were compared between the two groups.

          Results

          The BCVA of the IVR group was significantly improved at 1, 3 and 6 months compared with the preoperative BCVA ( P < 0.01). The BCVA of the control group was significantly improved at 3 and 6 months compared with the preoperative BCVA ( P < 0.01), but was not significantly improved at 1 month. At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months. The CMT of the IVR group was thinner than that of the control group at 1 and 3 months ( P < 0.01), with no significant difference at 6 months after surgery. The surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade were significantly different between the two groups (all P < 0.05). There was no significant difference between the two groups in terms of postoperative complications.

          Conclusions

          Ranibizumab pretreatment may improve the outcome of PPV with ILM peeling for severe PDR with ME by decreasing ME and intraoperative complications.

          Electronic supplementary material

          The online version of this article (10.1007/s13300-020-00822-0) contains supplementary material, which is available to authorized users.

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          Most cited references23

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          Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results.

          Michael Beck, N Bressler, Caleb Glassman … (2012)
          To report the 3-year follow-up results within a previously reported randomized trial evaluating prompt versus deferred (for ≥24 weeks) focal/grid laser treatment in eyes treated with intravitreal 0.5 mg ranibizumab for diabetic macular edema (DME). Multicenter, randomized clinical trial. Three hundred sixty-one participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and random assignment to prompt or deferred (≥24 weeks) focal/grid laser treatment. Best-corrected visual acuity and safety at the 156-week (3-year) visit. The estimated mean change in visual acuity letter score from baseline through the 3-year visit was 2.9 letters more (9.7 vs. 6.8 letters; mean difference, 2.9 letters; 95% confidence interval, 0.4-5.4 letters; P = 0.02) in the deferral group compared with the prompt laser treatment group. In the prompt laser treatment group and deferral group, respectively, the percentage of eyes with a ≥10-letter gain/loss was 42% and 56% (P = 0.02), whereas the respective percentage of eyes with a ≥10-letter gain/loss was 10% and 5% (P = 0.12). Up to the 3-year visit, the median numbers of injections were 12 and 15 in the prompt and deferral groups, respectively (P = 0.007), including 1 and 2 injections, respectively, from the 2-year up to the 3-year visit. At the 3-year visit, the percentages of eyes with central subfield thickness of 250 μm or more on time-domain optical coherence tomography were 36% in both groups (P = 0.90). In the deferral group, 54% did not receive laser treatment during the trial. Systemic adverse events seemed to be similar in the 2 groups. These 3-year results suggest that focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better, and possibly worse, for vision outcomes than deferring laser treatment for 24 weeks or more in eyes with DME involving the fovea and with vision impairment. Some of the observed differences in visual acuity at 3 years may be related to fewer cumulative ranibizumab injections during follow-up in the prompt laser treatment group. Follow-up through 5 years continues. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema.

            R Edwards, Melissa C. Greven, Ingrid Scott … (2007)
            To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME). Randomized phase II clinical trial. One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320. Random assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22). Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks. At baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3). These results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose.
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              A review of clinical trials of anti-VEGF agents for diabetic retinopathy.

              P Nicholson, Andrew Schachat (2010)
              Diabetic retinopathy (DR) is a leading cause of vision loss in the working-age population worldwide. Many observational and preclinical studies have implicated vascular endothelial growth factor (VEGF) in the pathogenesis of DR, and recent successes with anti-VEGF therapy for age-related macular degeneration (AMD) have prompted research into the application of anti-VEGF drugs to DR. Here we review the numerous early studies that suggest an important potential role for anti-VEGF agents in the management of diabetic retinopathy. For diabetic macular edema, phase II trials of intravitreal pegaptanib and intravitreal ranibizumab have shown short-term benefit in visual acuity. Intravitreal bevacizumab also has been shown to have beneficial short-term effects on both visual acuity and retinal thickness. For proliferative diabetic retinopathy (PDR), early studies suggest that intravitreal bevacizumab temporarily decreases leakage from diabetic neovascular lesions, but this treatment may be associated with tractional retinal detachment (TRD). Furthermore, several studies indicate that bevacizumab is likely to prove a helpful adjunct to diabetic pars plana vitrectomy (PPV) for TRD. Finally, three small series suggest a potential beneficial effect of a single dose of bevacizumab to prevent worsening of DME after cataract surgery. Use of anti-VEGF medications for any of these indications is off-label. Despite promising early reports on the safety of these medications, we eagerly await the results of large, controlled trials to substantiate the safety and efficacy of anti-VEGF drugs for diabetic retinopathy.
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                Author and article information

                Contributors
                Ning-ning Liu: ningning1688@126.com
                Journal
                Journal ID (nlm-ta): Diabetes Ther
                Journal ID (iso-abbrev): Diabetes Ther
                Title: Diabetes Therapy
                Publisher: Springer Healthcare (Cheshire )
                ISSN (Print): 1869-6953
                ISSN (Electronic): 1869-6961
                Publication date (Electronic): 30 April 2020
                Publication date PMC-release: 30 April 2020
                Publication date (Print): June 2020
                Volume: 11
                Issue: 6
                Pages: 1397-1406
                Affiliations
                GRID grid.412636.4, The Department of Ophthalmology, , First Affiliated Hospital of China Medical University, ; Shenyang, Liaoning Province China
                Article
                Publisher ID: 822
                DOI: 10.1007/s13300-020-00822-0
                PMC ID: 7261291
                PubMed ID: 32356244
                SO-VID: b3f28e5d-95ce-4ea7-b342-a8b072b8c221
                Copyright © © The Author(s) 2020
                History
                Date received : 29 February 2020
                Categories
                Subject: Brief Report
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: diabetic macular edema,proliferative diabetic retinopathy,ranibizumab,vitrectomy with internal limiting membrane peeling
                Data availability:
                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: diabetic macular edema, proliferative diabetic retinopathy, ranibizumab, vitrectomy with internal limiting membrane peeling

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