Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

Sponsor
Centro de Pesquisa Rubens Siqueira
Study ID
NCT07348588
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Extensive Macular Atrophy With Pseudodrusen (EMAP)
  • Retinitis Pigmentosa (RP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Adalimumab — DRUG
    Participants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4).

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2026
Primary completion
Aug 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intravitreal injection of adalimumab
    Participants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4). This arm evaluates the effect of anti-TNF-α immunomodulation alone on visual function and retinal structure in patients with Retinitis Pigmentosa and EMAP.

Primary Outcome Measure

Change in Field Preservation Deviation Index (FPDI) [ Time Frame: Baseline to Month 6 ]

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