A pilot study to assess the efficiency of Lamivudine, a drug used to treat HIV, in retinal edema due to vein occlusio

Phase 3

• Conditions: Health Condition 1: H348- Other retinal vascular occlusions

• Registration Number: CTRI/2024/04/065756
• Lead Sponsor: Aravind Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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