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ACTIVE NOT RECRUITING
NCT07348588
PHASE1/PHASE2

Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

Sponsor: Centro de Pesquisa Rubens Siqueira

View on ClinicalTrials.gov

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

DRUG

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