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To predict the efficacy of intravitreal pharmacotherapy for chronic diabetic macular edema using tear inflammatory markers.

Randomized and Controlled Comparative tear analysis for predicting the efficacy of intravitreal steroid implant (Ozurdex) and Anti Vascular Endothelial Growth Factor (VEGF) agents in chronic Diabetic Macular Edema (DME)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038325
Enrollment
90
Registered
2021-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: Intravitreal pharmacotherapy: To evaluate tear inflammatory markers by a multiplex ELISA method for MMP2 & 9, IL6, C3, endothelin, VEGF, TNF alpha etc. at / after Ozurdex injection in p

Sponsors

LV Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: We will include 60 patients with chronic DME defined as: â??Patients who have received at least 3 or more anti VEGF injections in past, but have persistent Centre involving DME (CIDME) at least 1 month or more after the last anti VEGF injection.â?? These shall be randomized to therapy. 30 patients further with NPDR without CIDME who are not being treated will be included for tear analysis only, to serve as baseline controls.

Exclusion criteria

Exclusion criteria: a) PDR, b) Retinal laser, c) surgery or eye disease other than cataract, d) Dry eye more than mild stage defined with Schirmer test, e) usage of topical NSAIDS f) NSAIDS/steroids/ Immunotherapy topical agents in last 1 month g) Hba1c > 7.5 or FBS >150 or BP > 180/100

Design outcomes

Primary

MeasureTime frame
a) Can tear inflammatory markers be used to predict the efficacy of intravitreal pharmacotherapy (steroids vs Anti VEGF) in the treatment of diabetic macular edema.Timepoint: 2 weeks, 1 month, 3 months—

Secondary

MeasureTime frame
b) Can tear film markers be used as a tool for screening and monitoring of DR and DME progression. Timepoint: day 0, 2 week, 1 month, 3 months , 6 months—

Countries

India

Contacts

Public ContactDrAkash Belenje

L V Prasad Eye Institute

akash.belenje@lvpei.org08951638899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026