Diabetic retinopathy
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind clinical trial. The intervention group will have 20 eyes with diabetic macular edema, patients will receive 150mg of Lamivudine twice a day for
D03.383.742.680.245.500.950.500
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactFelipe Pereira
Universidade Federal de São Paulo
Outcome results
None listed