Health Condition 1: H348- Other retinal vascular occlusions
Conditions
Interventions
Intervention1: Lamivudine: oral tablet - 150mg twice daily for 3 months
Control Intervention1: nil: nil
Sponsors
Aravind Eye Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1)patients with documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion. 2)patients with ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Study Eye only: 1)Evidence of iris, anterior chamber angle or retinal/optic disc neovascularization 2)Ocular disorders/additional eye disease, which in the opinion of the Investigator may confound interpretation of study results, compromise protocol assessments or are likely to require intervention during the study, including, but not limited to, atrophy of the retinal pigment epithelium, sub-retinal fibrosis, organized hard exudate plaque, clinically significant diabetic macular edema, retinal detachment, macular hole, vitreomacular traction, macular epiretinal membrane, clinically significant cataract, vitreal opacities or hemorrhage, glaucoma with documented visual field loss, ischemic optic neuropathy, retinitis pigmentosa or choroidal neovascularization of any cause (e.g., Age-related Macular Degeneration (AMD), ocular histoplasmosis, toxoplasmosis, or pathologic myopia) 3)Receipt within the past 6 months prior to the Screening Visit of any intraocular or periocular surgery (including refractive surgery, cataract surgery), or intravitreal (IVT) injection, or planned intraocular surgery or procedure during the study Both Eyes: 1)History of glaucoma or an IOP greater than 21 mmHg 2)Previous use of intraocular or periocular steroids within 3 months prior to baseline, or dexamethasone intravitreal implant within 6 months prior to baseline 3)History of, or presence of uveitis, presence of intraocular inflammation 4)History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab,bevacizumab,aflibercept,etc), macular laser photocoagulation (focal/grid),panretinal laser photocoagulation, vitrectomy, trabeculectomy or keratoplasty in the study eye at any time prior to baseline. YAG laser treatment or any other intraocular surgeries (e.g. cataract surgery) in the study eye within 6 months prior to the baseline 5)Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens, or optic nerve (e.g., desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol). 6)History of impaired renal or liver function 7)Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal value in the local laboratory). Renal function impairment (Cr is 1.5 times higher than the upper limit of normal values in the local laboratory) 8)Women in pregnancy and lactation 9)Individuals with HIV, HBV, or who have current/previous use of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or non-NRTIs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Best-corrected visual acuity (BCVA) [ Time Frame: Baseline to Week 12]. Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts at baseline and Weeks 2,4,8 and 12.Timepoint: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Foveal Avascular Zone (FAZ) and Vessel Density (VD). [ Time Frame: Baseline to Week 12]. Assessed with Optical Coherence Tomography Angiography (OCTA) at baseline and Weeks 2,4,8 and 12Timepoint: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks;Macular Function Using multi-focal electroretinogram (mf-ERG) [ Time Frame: baseline to 12 weeks ] To determine if there is a change in central amplitude responses using mfERG at 12 weeks compared to baseline valuesTimepoint: baseline, 12 weeks;Mean change from baseline Center Subfield Macular Thickness (CMT). [ Time Frame: Baseline to Week 12]. Assessed with Spectral Domain Optical Coherence Tomography (SD-OCT) at baseline and Weeks 2,4,8 and 12.Timepoint: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks;Mean change from baseline in contrast sensitivity. [ Time Frame: Baseline to Week 12]. Assessed with MARS Contrast sensitivity test at baseline and Weeks 2,4,8 and 12.Timepoint: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks;Safety - laboratory parameters [ Time Frame: 12 weeks] assessed by Liver and Renal function tests at baseline and week 12.Timepoint: baseline, 12 weeks | — |
Countries
India
Contacts
Public ContactDr Siddharth Narendran
Aravind Eye Hospital, Coimbatore
Outcome results
None listed