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Clinical Trials/CTRI/2024/04/065756
CTRI/2024/04/065756
Not yet recruiting
Phase 3

Pilot study to assess the efficacy of oral Lamivudine for macular edema due to retinal vein occlusions - NI

Aravind Eye Hospital0 sites0 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: H348- Other retinal vascular occlusions
Sponsor
Aravind Eye Hospital
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • 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
  • 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

Outcomes

Primary Outcomes

Not specified

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