NCT07348588Active, not recruitingPhase 1/2
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Nov 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 5 Feb 2026
- Lead sponsor
- Centro de Pesquisa Rubens Siqueira
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT07348588
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 10 Jul 2025 to the primary completion date, 5 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled glaucoma (intraocular pressure \> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.
- 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.
- Participation in another interventional clinical trial within 3 months prior to enrollment.
Other illness
- 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.
- Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any formulation components.
- Uncontrolled systemic disease that increases risk or interferes with study participation or completion.
Lab values
- Coagulopathy or contraindications to ocular injections (platelet count \< 100,000/µL or INR \> 1.5 unless corrected).
Other
- Significant media opacity that may impair imaging quality or safe intravitreal injection.
- Recent ocular interventions that may confound study outcomes, including:
- Pregnancy or breastfeeding.
- Women of childbearing potential unwilling to use effective contraception during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rubens Siqueira Research Center Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.