Health Condition 1: H358- Other specified retinal disorders
Conditions
Interventions
Intervention1: Anti-VEGF Standard Therapy: Drug: Ranibizumab or Aflibercept (as per hospital protocol)
Route: Intravitreal injection
Dosage Regimen: 0.5 mg Ranibizumab / 2 mg Aflibercept intravitrea
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with center-involving diabetic macular edema (CI-DME) confirmed by optical coherence tomography (OCT). 2.Age more than 18 years at the time of first treatment. 3.Received anti-VEGF therapy (Ranibizumab, Aflibercept, or Bevacizumab) between January 2018 and March 2025 at Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi. 4.Minimum follow-up duration of 6 months post initial anti-VEGF injection. 5.Availability of complete clinical records including: a.Best-corrected visual acuity (BCVA) b.Central retinal thickness (CRT) c.Cost data (direct and indirect) 6.Patients who have provided general consent for retrospective use of data or where waiver of consent is approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1.Eyes with prior vitreoretinal surgery or any intraocular surgery (except uncomplicated cataract surgery) within 6 months before anti-VEGF initiation. 2.Co-existing ocular diseases affecting vision (e.g., age-related macular degeneration, retinal vein occlusion, advanced glaucoma). 3.Patients who received combination therapy (e.g., anti-VEGF + steroid or laser) during the study period (unless separate groups are analyzed). 4.Inadequate imaging or clinical data preventing assessment of visual or anatomical outcomes. 5.Non-adherence to treatment or follow-up, resulting in fewer than 3 documented visits post initiation. 6.History of systemic conditions severely affecting functional status or vision-related quality of life assessment (e.g., stroke, severe neurological disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in best-corrected visual acuity (BCVA) measured in ETDRS letters, used to determine cost-effectiveness of anti-VEGF therapy versus comparators.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, and 52 weeks (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in best-corrected visual acuity (BCVA) in ETDRS letters Change in central macular thickness (CMT) on spectral-domain OCT Indirect costs including lost workdays, travel, and caregiver burden Change in vision-related quality of life using validated questionnaire (e.g., NEI VFQ-25 or EQ-5D)Timepoint: Baseline 3 months 6 months 12 months | — |
Countries
India
Contacts
Public ContactDr Sanjay Kumar Mishra
AIIMS, New Delhi
Outcome results
None listed