Trials / NCT07348588
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Underway, not enrolling Phase 1 / Phase 2 Drug / neuroprotection
- Sponsor
- Centro de Pesquisa Rubens Siqueira
- Treatment
- Intravitreal Adalimumab
- Gene
- Not stated
- Conditions
- Retinitis Pigmentosa (RP), Extensive Macular Atrophy With Pseudodrusen (EMAP)
- Ages
- 18 Years to 80 Years
- Enrollment
- 30 participants
- Started
- 2025-07-10
- Main results expected
- 2026-02-05
- Results posted
- Not yet
- Record last updated
- 2026-10-27
What the study is testing
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.
Where it runs
Brazil (1)
- Rubens Siqueira Research Center, São José do Rio Preto, São Paulo