Augusto A L Motta1, Maria Teresa B C Bonanomi2, Daniel A Ferraz3, Rony C Preti2, Raafay Sophie4, Maria F Abalem2, Marcia S Queiroz5, Sérgio L G Pimentel2, Walter Y Takahashi2, Francisco M Damico2. 1. Division of Ophthalmology, University of São Paulo, São Paulo Medical School, São Paulo, Brazil. Electronic address: medmotta@hotmail.com. 2. Division of Ophthalmology, University of São Paulo, São Paulo Medical School, São Paulo, Brazil. 3. Division of Ophthalmology, University of São Paulo, São Paulo Medical School, São Paulo, Brazil; Ocular Imaging Research & Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska, United States. 4. Department of Ophthalmology & Visual Sciences, University of Louisville, United States. 5. Division of Endocrinology & Metabolism, Department of Diabetes, University of São Paulo, São Paulo Medical School, São Paulo, Brazil.
Abstract
AIMS: To analyze contrast sensitivity of intravitreal bevacizumab injections with optimizing glycemic control versus optimizing glycemic control (in combination with sham injections) in eyes with Diabetic Macular Edema (DME). DESIGN: Prospective, interventional, masked, randomized controlled trial. METHODS:Forty-one eyes of 34 patients with type 2 diabetes mellitus and DME with glycated hemoglobin (HbA1c) < 11% received eitherintravitreal bevacizumab injection (Group 1) or sham injection (Group 2) at 0 and 6 weeks along with optimizing glycemic control. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS), optical coherence tomography (OCT)-measured by central macular thickness (CMT) were compared and correlated at baseline, 2, 6 and 12 weeks. RESULTS: The study showed a mean CS improved in group 1 from 1.14 ± 0.36 logCS to 1.32 ± 0.24 logCS and also in group 2 from 1.11 ± 0.29 logCS to 1.18 ± 0.29 logCS at 12 weeks (P = 0.12). CS and CMT promptly decreased in group 1 compared to group 2 at 2 weeks (ΔCS = 0.15 ± 0.25 vs. 0.03 ± 0.15 logCS; P = 0.04; ΔCMT = 116 ± 115 vs. 17 ± 71 μm; P = 0.01). There was a mean reduction of approximately 0.5% in HbA1c levels in both groups at 12 weeks (P = 0.002). CONCLUSION: The use of bevacizumab in combination with optimizing glycemic control results in earlier improvement of contrast sensitivity in type 2 diabetes patients with DME. However, the optimizing glycemic control itself has shown also to be effective at 12 weeks. ClinicalTrials.gov Identifier: NCT02308644.
RCT Entities:
AIMS: To analyze contrast sensitivity of intravitreal bevacizumab injections with optimizing glycemic control versus optimizing glycemic control (in combination with sham injections) in eyes with Diabetic Macular Edema (DME). DESIGN: Prospective, interventional, masked, randomized controlled trial. METHODS: Forty-one eyes of 34 patients with type 2 diabetes mellitus and DME with glycated hemoglobin (HbA1c) < 11% received either intravitreal bevacizumab injection (Group 1) or sham injection (Group 2) at 0 and 6 weeks along with optimizing glycemic control. Mean change in best-corrected visual acuity (BCVA), contrast sensitivity (CS), optical coherence tomography (OCT)-measured by central macular thickness (CMT) were compared and correlated at baseline, 2, 6 and 12 weeks. RESULTS: The study showed a mean CS improved in group 1 from 1.14 ± 0.36 logCS to 1.32 ± 0.24 logCS and also in group 2 from 1.11 ± 0.29 logCS to 1.18 ± 0.29 logCS at 12 weeks (P = 0.12). CS and CMT promptly decreased in group 1 compared to group 2 at 2 weeks (ΔCS = 0.15 ± 0.25 vs. 0.03 ± 0.15 logCS; P = 0.04; ΔCMT = 116 ± 115 vs. 17 ± 71 μm; P = 0.01). There was a mean reduction of approximately 0.5% in HbA1c levels in both groups at 12 weeks (P = 0.002). CONCLUSION: The use of bevacizumab in combination with optimizing glycemic control results in earlier improvement of contrast sensitivity in type 2 diabetespatients with DME. However, the optimizing glycemic control itself has shown also to be effective at 12 weeks. ClinicalTrials.gov Identifier: NCT02308644.
Authors: Wesley T Beaulieu; Adam R Glassman; Carl W Baker; Maureen G Maguire; Chris A Johnson; Michele Melia; Jennifer K Sun Journal: Transl Vis Sci Technol Date: 2021-03-01 Impact factor: 3.048