amivudine for Retinal Edema in Diabetic Patients

Phase 2

• Conditions: Diabetic retinopathy; Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema; Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema; 3942

• Registration Number: RBR-87b6r5s
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Study Completion: 2023-09-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

18 years old and older without gender restriction; Type 1 or 2 diabetes; Diabetic macular edema with central involvement; Central retinal thickness equal to or greater than 325 µm measured by spectral-domain optical coherence tomography (SD-OCT); Best-corrected visual acuity less than 74 letters measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) table.

Exclusion Criteria

High-risk proliferative diabetic retinopathy; Hemoglobin A1c (HbA1c) greater than 12; History of panphotocoagulation, macular laser, anti-VEGF injection, or intraocular corticosteroid implant within the past 6 months; Presence of retinal alteration that, at the assistant physician's discretion, will not improve visual acuity even with the resolution of macular edema (foveal atrophy, condensation of foveal hard exudates); Diagnosis of ocular alteration, in addition to diabetic macular edema, which may alter visual acuity throughout the study (neovascular glaucoma, retinal vein occlusion, or uveitis); Positive serology for human immunodeficiency virus (HIV) or hepatitis B virus (HBV); Liver failure, or less than 40 mL/min/1,73 m2 estimated Glomerular Filtration Rate; History of lactic acidosis; Proven or suspected pregnancy, breastfeeding

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcome will be the change in best-corrected visual acuity from baseline to week 4 and from baseline to week 8.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 1: change in SD-OCT central subfield thickness (CST) from baseline to week 4 and from baseline to week 8;;Expected outcome 2: percentage of eyes that achieved an improvement in BCVA of at least 10 letters or at least 15 letters from baseline to week 4 or week 8.;Expected outcome 3: assess the proportion of eyes with central retinal thickness less than 325µm at weeks 4 and 8 using optical coherence tomography