CTRI/2014/02/004379
Recruiting
Phase 4
A 12 month, open label, multi-center study to evaluate the efficacy and safety of intravitreal injections of ranibizumab 0.5 mg on Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME) - LUCID
Dr V Narendran0 sites300 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME)
- Sponsor
- Dr V Narendran
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients must be \>\=18 years of age who have signed an informed consent.
- •2\.Having Type 1 or Type 2 diabetes mellitus.
- •3\.Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
- •4\.BCVA score between 78 and 39 letters, inclusively, using ETDRS\-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160\).
- •5\.Retinal thickness \>250 µm by OCT.
- •6\.OCT scan acquisition possible.
Exclusion Criteria
- •A) Presence of Ocular concomitant conditions/ diseases
- •1\.Active intraocular inflammation (grade trace or above) in either eye.
- •2\.Any active infection (e.g. keratitis, scleritis, uveitis, endophthalmitis) in either eye
- •3\.History of uveitis in either eye.
- •4\.Structural damage within 0\.5 disc diameter of the center of the macula in the study eye, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.
- •5\.Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12\-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia).
- •6\.Uncontrolled glaucoma in either eye.
- •7\.Neovascularization of the iris in either eye.
- •8\.Evidence of vitreomacular traction in either eye.
- •9\.Active proliferative diabetic retinopathy in the study eye (active PDR means below)
Outcomes
Primary Outcomes
Not specified
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