CTRI/2022/08/044792
Recruiting
Phase 4
A Phase IV interventional post approval trial to assess the safety of intravitreal aflibercept for the treatment of diabetic macular edema (DME) in patients in India. - VISION AF
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H353- Degeneration of macula and posterior pole
- Sponsor
- Bayer Zydus Pharma Private Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female or male adult participant \>\=18 years of age, with type 1 or 2 diabetes mellitus.
- •2\. Participant must have DME secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of OCT) in the study eye.
- •3\. Decrease in vision, determined to be primarily the result of DME in the study eye.
- •4\. Retinal thickness of \>\=300 µm in the study eye, as assessed by OCT.
- •5\. BCVA ETDRS letter score of 73 to 24 (i.e., VA of 20/50 to 20/320\) or equivalent in the study eye.
- •6\. Participant for whom the decision to initiate treatment with IVT aflibercept has been
- •made by the treating Investigator/Physician.
- •7\. Willing and able to comply with clinic visits and study\-related procedures.
- •8\. Provide a signed ICF prior to any study procedures.
Exclusion Criteria
- •1\. Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients).
- •2\. History of vitreoretinal surgery and/or scleral buckling in the study eye.
- •3\. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
- •4\. Known history of allergy to fluorescein used in fluorescein angiography, and indocyanine green used in indocyanine green angiography. As indocyanine green dye contains iodine, so severe allergic reactions are possible in patients allergic to iodine.
- •5\. Any laser photocoagulation (panretinal or macular) in the study eye within the last 3
- •months of Day 1\.
- •6\. Any cataract surgery in the study eye within the last 3 months of Day 1\.
- •7\. Any intraocular surgery in the study eye within the last 3 months of Day 1\.
- •8\. Received previous/ prior treatment as mentioned below:
- •a) Received anti\-VEGF drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc., including aflibercept) within the last 3 months of Day 1\.
Outcomes
Primary Outcomes
Not specified
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