Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Injection Intravitreal Ranibizumab according to Treat- and-Extend: If the reduction in Central subfield thickness is more than 10% or, no Best corrected visual acuity decrease of more t
Sponsors
University college of medical sciences and Guru Teg Bahadur Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years with type 1 and type 2 DM. 2. Centre-involving DME (central subfield thickness more than equal to 250 micrometer) on spectral domain OCT 3. BCVA 20/40 to 20/200(70 to 35 ETDRS letters). 4. Clear ocular media cataract less than 2 plus LOCS III 5. Ability to give informed consent and comply with mfERG/CS testing.
Exclusion criteria
Exclusion criteria: 1. Proliferative DR requiring pan-retinal photocoagulation. 2. Significant macular ischemia (more than 1000 um FAZ) on fluorescein angiography. 3. Prior vitrectomy or intravitreal steroid in study eye. 4. Uncontrolled glaucoma (IOP more than 25 mmHg). 5. Anti-VEGF in study eye within 3 months. 6. Systemic anti-VEGF therapy, recent cardiovascular event (less than 3 months). 7. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in mfERG ring NIP1 response density in patients of diabetic macular edema treated with treat and extend regimen vs Pro Re Nata. 2. Change in contrast sensitivity in patients of diabetic macular edema treated with treat and extend regimen vs Pro Re NataTimepoint: Month 3 and Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity (BCVA)Timepoint: Baseline, month 3, month 6, month 12;central subfield thickness (CST um) using OCTTimepoint: Month 3, month 6, month 12;Number of injectionsTimepoint: 0 to 12 months;NEI-VFQ-25 questionnaireTimepoint: Month 6, Month 12 | — |
Countries
India
Contacts
Public ContactKrati Gupta
University college of medical sciences
Outcome results
None listed