CTRI/2024/04/065756尚未招募3 期
Pilot study to assess the efficacy of oral Lamivudine for macular edema due to retinal vein occlusions - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
- •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
研究者
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