Can an arthritis drug save sight? small trial tests adalimumab for rare eye diseases

NCT ID NCT07348588

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Extensive macular atrophy with pseudodrusen (EMAP) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.