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Last-Chance access: experimental eye treatment opens for 75 RP patients

NCT ID NCT06574997

Disease control Sponsor: Ocugen Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This program offers an experimental treatment called OCU400 to up to 75 adults with retinitis pigmentosa (RP) who cannot join the main Phase 3 study. Participants must be 18 or older, have a confirmed genetic diagnosis of RP (except a specific mutation), and have remaining light-sensing cells in the eye. The goal is to provide access when no approved alternative is available.

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.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

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: 1. Males or females ≥18 years of age at the time of informed consent. 2. Confirmed clinical and CLIA certified genetic diagnosis of RP (except subjects with AD-NR2E3 mutation) 3. Presence of photoreceptors as determined by spectral-domain optical coherence tomography (SD-OCT). Exclusion Criteria: 1. Subject lacks evidence of outer nuclear layer, i.e., containing the nuclei of the retinal photoreceptors as determined by SD- OCT. 2. Considered unsuitable for any reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, or the Sponsor after reviewing the subject medical history and condition. 3. Previous treatment with a gene-therapy or cell therapy product, excluding OCU400. 4. Previous treatment with any investigational drug or device within one year, excluding OCU400. 5. Any contraindications for subretinal injection. 6. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months

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Conditions

The condition(s) this trial relates to.

retinitis pigmentosa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinitis pigmentosa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Research

    AVAILABLE

    Deerfield Beach, Florida, 33064, United States

  • Associated Retina Consultants

    AVAILABLE

    Phoenix, Arizona, 85020, United States

  • Erie Retina Research

    AVAILABLE

    Erie, Pennsylvania, 16507, United States

  • Gundersen Health

    AVAILABLE

    La Crosse, Wisconsin, 54601, United States

  • Valley Retina Institute

    AVAILABLE

    McAllen, Texas, 78503, United States

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