Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

NCT07348588 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: ADARET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

retinitis pigmentosa; intravitreal adalimumab; visual field; ERG; Ellipsoid zone; retinal degeneration

Outcome Measures

Primary Outcomes (3)

• Change in Field Preservation Deviation Index (FPDI)

  Change (Δ) in Field Preservation Deviation Index (FPDI), expressed as a percentage (%), measured by automated perimetry using the iCare COMPASS system. The FPDI reflects the proportion of preserved visual field relative to age-matched normative data and provides a quantitative assessment of global visual field integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 values in the study eye.

  Baseline to Month 6

• Change in Mean Deviation (MD)

  Change (Δ) in Mean Deviation (MD), expressed in decibels (dB), measured by automated perimetry using the iCare COMPASS system. Mean Deviation represents the average difference in retinal sensitivity compared with age-adjusted normative values, serving as a global index of visual field loss. The outcome corresponds to the difference between baseline (Month 0) and Month 6 measurements in the study eye.

  Baseline to Month 6

• Change in Best-Corrected Visual Acuity (BCVA)

  Change (Δ) in Best-Corrected Visual Acuity (BCVA), expressed in logarithm of the minimum angle of resolution (LogMAR), measured using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) charts under controlled testing conditions. BCVA assesses central visual function and foveal integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 BCVA values in the study eye.

  Baseline to Month 6

Secondary Outcomes (4)

• Change in Pattern Standard Deviation (PSD)

  Baseline to Month 6

• Change in 30-Hz Flicker ERG Amplitude

  Baseline to Month 6

• Change in Central Macular Thickness (CMT)

  Baseline to Month 6

• Change in Ellipsoid Zone (EZ) Length

  Baseline to Month 6

Study Arms (1)

intravitreal injection of adalimumab

EXPERIMENTAL

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.

Drug: Intravitreal Adalimumab

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).

intravitreal injection of adalimumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance) confirmed by multimodal evaluation.
• Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye.
• Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices.
• Clear ocular media adequate for safe intravitreal injection and high-quality OCT imaging.
• Ability and willingness to provide written informed consent.
• Ability to comply with scheduled study visits (Baseline \[M0\], Day 7-14 after injections, Month 2 \[M2\], Day 7-14, Month 4 \[M4\], Day 7-14, and Month 6 \[M6\]).
• For ERG subset only: presence of a recordable baseline 30-Hz flicker ERG response (signal-to-noise ratio ≥ 3:1 and amplitude ≥ 3.0 µV).
• Note: Absence of a measurable flicker ERG response does not exclude participation in the main study.

You may not qualify if:

• Active ocular inflammation (anterior, intermediate, or posterior uveitis) or infectious ocular disease in the study eye.
• Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP.
• Uncontrolled glaucoma (intraocular pressure \> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.
• Significant media opacity that may impair imaging quality or safe intravitreal injection.
• Recent ocular interventions that may confound study outcomes, including:
• Intravitreal therapy within 3 months prior to enrollment.
• Periocular corticosteroid injection within 3 months prior to enrollment.
• Major intraocular surgery within 3 months prior to enrollment.
• Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any formulation components.
• Coagulopathy or contraindications to ocular injections (platelet count \< 100,000/µL or INR \> 1.5 unless corrected).
• Pregnancy or breastfeeding.
• Women of childbearing potential unwilling to use effective contraception during the study period.
• Uncontrolled systemic disease that increases risk or interferes with study participation or completion.
• Participation in another interventional clinical trial within 3 months prior to enrollment.

Sponsors & Collaborators

• Centro de Pesquisa Rubens Siqueira: lead

Study Sites (1)

Rubens Siqueira Research Center

São José do Rio Preto, São Paulo, 15010-100, Brazil

Location

Related Publications (1)

• Siqueira RC, Brandao CC. The Role of Cytokines in Degenerative Retinal Diseases: A Comprehensive Review. Biomedicines. 2025 Jul 15;13(7):1724. doi: 10.3390/biomedicines13071724.

  PMID: 40722794 BACKGROUND

MeSH Terms

Conditions

Retinitis Pigmentosa; Retinal Degeneration

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: his is a prospective, single-arm, open-label interventional pilot study designed to assess the ocular safety, feasibility, and functional outcomes of intravitreally administered adalimumab in patients with retinitis pigmentosa. All participants receive the same intervention-adalimumab 2 mg/0.05 mL-administered at baseline (M0), and at two-month intervals (M2, M4), for a total of three injections. Given the exploratory nature and rarity of the condition, no randomization or masking is applied. Each participant serves as their own control, with outcomes evaluated as within-subject pre-post changes from baseline to six months (M0-M6). The study is structured to provide proof-of-concept data regarding the therapeutic potential of local TNF-α inhibition in inherited retinal degenerations. This model prioritizes real-world applicability, tolerability, and early detection of functional trends (visual acuity, field sensitivity, ERG, and OCT biomarkers) to inform the design of future controlled

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 16, 2026
• Study Start: March 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

BR (1)