Clinical Research Directory
Browse clinical research sites, groups, and studies.
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Sponsor: Centro de Pesquisa Rubens Siqueira
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.
Official title: Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-01
Completion Date
2026-12-01
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
Intravitreal Adalimumab
Participants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4).
Locations (1)
Rubens Siqueira Research Center
São José do Rio Preto, São Paulo, Brazil