Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

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.

NCT Number	NCT07348588
Lead Sponsor	Centro de Pesquisa Rubens Siqueira
Conditions	Retinitis Pigmentosa (RP), Extensive Macular Atrophy With Pseudodrusen (EMAP)
Enrollment	30 participants
Start Date	2025-07-10
Primary Completion	2025-08-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30