drugset / Trial / NCT07348588

Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

NCT07348588

Phase 1/2 Active not recruiting 30 enrolled Centro de Pesquisa Rubens Siqueira
NaSingle-groupOpen-labelTreatment

Summary

This prospective, comparative pilot study investigates the safety and functional outcomes of intravitreal adalimumab (ADA) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Participants will receive three intravitreal injections of adalimumab (2 mg/0.05 mL) at two-month intervals (M0, M2, M4). The primary objective is to assess functional changes after 6 months, focusing on visual-field preservation (Field Preservation Deviation Index - FPDI, Mean Deviation - MD) and best-corrected visual acuity (LogMAR). Secondary outcomes include alterations in 30-Hz flicker ERG amplitude, OCT parameters (central macular thickness and ellipsoid zone length), and ocular safety measures such as intraocular pressure and inflammatory response.

Timeline

Start
2025-07-10
Primary completion
2025-08-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 2 mg Intravitreal

Indications