Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: Intravitreal Injection:
Injection aflibercept 2mg/.05ml or injection ranibizumab 0.5mg/.05ml
: Intravitreal Injection:
Injection aflibercept Dose: 2mg/.05ml or injection ranibizumab 0.5
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients age = 18 years. 2. Patients with type 1 or type 2 diabetes mellitus with Non proliferative diabetic retinopathy + treatment naive central diabetic macular edema or treated Proliferative diabetic retinopathy + central diabetic macular edema (defined as retinal thickening with a measurement of 300µm or more involving the 1 mm CRT by SS-OCT). 3. No prior history of Intravitreal Anti VEGF in either eye and laser photocoagulation done in last 3 months. 4. The cause of decreased vision in the study eye attributed primarily to DME. 5. BCVA in Snellen visual acuity of 20/40 to 20/320 in the study eye. 6. In female in child bearing age, a negative serum pregnancy test before enrollment, and should not be nursing or planning a pregnancy.
Exclusion criteria
Exclusion criteria: 1. Media haze that would interfere with good imaging. 2. Known hypersensitivity to fluorescein 3. History of vitreoretinal surgery in study eye and/or including scleral buckling. 4. Pan retinal or macular laser photocoagulation within 3 months of randomization 5. Active ocular inflammation or uveitis 6. Cataract or other intraocular surgery within 3 months of enrollment into the study 7. Aphakia 8. Visually significant vitreomacular traction or epiretinal membrane evident biomicroscopically or on OCT that is thought to affect central vision. 9. Active iris neovascularisation 10. Preretinal fibrosis involving the macula. 11. Active or suspected ocular or peri-ocular infection like infectious blepharitis, keratitis, scleritis, or conjunctivitis 12. Uncontrolled diabetes mellitus as defined by HbA1c =10% at screening. 13. Uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm of Hg. 14. History of cerebrovascular accident or myocardial infarction within 6 months. 15. Renal failure requiring dialysis or renal transplant. 16. Co morbidities like vein occlusions, retinal detachment etc. that may contribute to visual loss.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To correlate imaging and molecular biomarkers pre and post Anti VEGF injections in patients with diabetic macular edema. 2.To identify imaging & molecular biomarkers that can help in identifying responders from non-responders to Anti-VEGF therapy.Timepoint: outcome will be studies at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Vipin Rana
PGIMER, CHANDIGARH
Outcome results
None listed