Prospective comparative trial of Treat-and-Extend versus Pro re nata versus Fixed Dosing Regimens of Faricimab 6.0mg in Diabetic Macular Edema in the Indian Population

Prospective,Randomized Open- Label,Parallel-group comparative trial of Treat-and-Extend versus Pro re nata versus Fixed Dosing Regimens of Faricimab 6.0mg in Diabetic Macular Edema in the Indian Population - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107403

Enrollment

144

Registered

2026-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: E133- Other specified diabetes mellituswith ophthalmic complications

Interventions

Intervention1: Faricimab 6.0mg Treat-and-Extend regimen: Intravitreal Faricimab 6.0mg 4 weekly with dosing interval increment by two weeks on every visit when re treatment criteria are not met Interve

Eligibility

Inclusion criteria

Inclusion criteria: Documented Diagnosis of Diabetic Macular Edema, Type 2 Diabetes Mellitus, Best Corrected Visual Acuity between 6/6 and 3/60 in the affected eye, Provide written informed consent

Exclusion criteria

Exclusion criteria: Patient who denies written informed consent, No baseline data of his/her visit Macular edema due to causes other than DME(e.g. Retinal vascular occlusions, uveitis) Pregnancy or lactation poor glycemic control systemic contraindications to Anti-VEGF therapy

Design outcomes

Primary

Measure	Time frame
To compare change in BCVA from baseline among treat and extend, pro re nata, fixed dosing regimens of Intravitreal faricimab anti-VEGF injectionsTimepoint: 5-6 months	—

Secondary

Measure	Time frame
Change in central macular thickness, total number of Injections, OCT biomarker response,To assess safety outcomesTimepoint: 5-6 months	—

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Army Hospital RR

eyepradeep@yahoo.com9560034515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026