Can an arthritis drug save sight? small trial tests adalimumab for rare eye diseases
NCT ID NCT07348588
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This pilot study tests whether adalimumab, an anti-inflammatory drug, can help preserve vision in people with retinitis pigmentosa or a related condition called EMAP. Thirty participants will receive three injections into the eye over four months. The main goal is to see if the treatment slows vision loss and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adalimumab (a drug that reduces inflammation) injected into the eye
- What this could lead to
- If it works, this could point toward a treatment that slows vision loss in certain inherited retinal diseases.
- What could go wrong
- This is a very early, small pilot study with only 30 people. It may not show clear benefit, and eye injections carry risks like infection or inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rubens Siqueira Research Center
São José do Rio Preto, São Paulo, 15010-100, Brazil
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Other studies related to the condition(s) this trial covers.
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