A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema

Recruiting Phase 3 Interventional Study
Diabetic Macular Edema Diabetic Retinopathy Macular Edema Macular Degeneration Retinal Disease Retinal Degeneration
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Incepta Pharmaceuticals Ltd · Industry
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About This Trial
Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to in…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ages Eligible for Study: ≥ 18 Years 2. Ability to provide written informed consent and comply with study assessments for the full duration of the study 3. Diagnosis of diabetes mellitus (type 1 or 2). Any one of the following will be considered to be sufficient evidence that …
Contacts

Faez Ahmed

+880-2-8891688-703

faez@inceptapharma.com

CONTACT