Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: INTRAVITREAL INJECTION: The eye undergoing treatment with injection will be prepared by applying 5% povidone iodine under aseptic precautions, an eyelid speculum will be placed and unde
Sponsors
Sri Devaraj Urs Academy of higher education and research
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients with Type-1 and Type-2 diabetes mellitus between 18 years to 65 years of age of both genders 2. Patients with severe NPDR or proliferative DR in both eyes with or without clinically significant macular edema (CSME) established by optical coherence tomography of Central Macular Thickness greater than 300 microns were included in the study 3. Visual impairment due to Diabetic Macular Edema in at least one eye 4. HbA1c Less than 10.0 5. High risk Proliferative Diabetic Retinopathy
Exclusion criteria
Exclusion criteria: 1. History of prior laser treatment or vitrectomy in the study eye 2. Major surgery within the prior 6 months or planned within the next 28 days 3. Uncontrolled hypertension 4. Those patients with mature cataract or media opacities due to poor quality Optical Coherence Tomography images were all excluded from the study 5. Previous use of intravitreal corticosteroid application in phakic study eyes or chronic treatment with topical ocular or systemic corticosteroids 6. Those with previous treatment with anti angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.,) within three months of the day 0 (first day of treatment) visit. 7. Those with Proliferative Diabetic Retinopathy (PDR) in the study eye, iris neovascularization, vitreous hemorrhage, traction retinal detachment, or pre retinal fibrosis involving the macula in the study eye 8. Uncontrolled glaucoma and ocular trauma 9. Any condition that could affect follow up or documentation (including pre retinal or vitreous hemorrhage) 10. Changes in the vitreous-retinal interface (epiretinal membrane, macular hole and vitreoretinal traction syndrome) 11. Prior Thromboembolic events including myocardial infarction, stroke and deep vein thrombosis 12. Chronic Renal Failure 13.Decrease in vision due to other causes, vitreous hemorrhage, and concomitant conditions in the study eye or other ocular disorders that may confound interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of ranibizumab on Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMT) every monthly in both groupsTimepoint: month 3 to 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| Regression of Neovascularization: total Neovascularization Disc + Neovascularization Elsewhere (NVD+ NVE)Timepoint: Month 1 to 12 | — |
Countries
India
Contacts
Public ContactDr Inchara N
Sri Devaraj Urs Academy of higher education and research
Outcome results
None listed