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A study to evaluate the safety of REGN7041 in adults with active noninfectious uveitis affecting the back of the eye.

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Noninfectious Uveitis affecting the posterior segment, which refers to the back part of the eye. This condition involves inflammation in the eye that is not caused by an infection. The investigation aims to evaluate the safety and how well the body tolerates the study drug.

The treatment being tested is an anti-CD3 monoclonal antibody called REGN7041. This medication is provided as a solution for injection and is administered via intravitreal use, which means the medicine is injected directly into the jelly-like substance inside the eye. Participants may receive either a single dose or repeated doses of this substance during the course of the study.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of medication

    The medication REGN7041, which is a solution for injection, is administered through an intravitreal injection. This means the medicine is injected directly into the vitreous, which is the clear, gel-like substance located inside the back of the eye.

    The purpose of this administration is to evaluate how the body reacts to single or repeated doses of this substance.

  2. Step 2

    Safety and monitoring

    The process involves monitoring for any adverse events, which are any unexpected or unwanted medical side effects that occur during or after the treatment.

    Blood samples are collected to measure the concentration of the medication in the serum, which is the clear part of the blood that remains after clotting.

    Blood samples are also used to check for the presence and amount of anti-drug antibodies. These are proteins produced by the immune system that may attempt to fight the medication.

Who can join the trial?

6 criteria

  • You must have a diagnosis of non-infectious uveitis, which is a type of inflammation inside the eye that is not caused by an infection like a virus or bacteria.
  • The inflammation must be present in different parts of the eye, such as the anterior (front), intermediate (middle), posterior (back), or panuveitis (affecting all parts of the eye).
  • If the inflammation is only in the front of the eye, there must also be evidence that it is affecting the posterior segment, which is the area at the back of the eye.
  • Your disease must be active, meaning the inflammation is currently ongoing at the start of the study.
  • For those in Part A of the study, your Best Corrected Visual Acuity, which is the best vision you can achieve while wearing glasses or contact lenses, must be between 10 and 65 letters on a standardized eye chart.
  • For those in Part B of the study, your Best Corrected Visual Acuity must be between 10 and 75 letters on a standardized eye chart.

Who cannot join the trial?

4 criteria

  • Your best-corrected visual acuity (the clearest vision you can achieve using glasses or contact lenses) must be better than 30 letters on a standard eye chart (which is similar to seeing 20/250 or worse).
  • Your intraocular pressure (the fluid pressure inside your eye) must not be lower than 5 mm Hg at the start of the study.
  • Your intraocular pressure (the fluid pressure inside your eye) must not be higher than 25 mm Hg on the first day of the study, though you may use eye drops to lower this pressure if allowed.
  • You cannot have infectious uveitis, which is an inflammation of the middle layer of the eye caused by an infection like a virus or bacteria.
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Investigated drugs

REGN7041 is an experimental medicine given by injection into the eye. It is designed to target and block a specific part of the immune system to help reduce inflammation in the back part of the eye.

What is already known about the treatment

REGN7041 - This medication is an experimental injection applied directly into the eye as a liquid solution to treat inflammation in the back part of the eye. Currently being studied in early-stage clinical trials, it is classified as an anti-CD3 monoclonal antibody designed to target specific cells in the immune system. At a molecular level, it works by attaching to and blocking a protein on the surface of certain immune cells to prevent them from causing harmful inflammation. This therapy is being investigated primarily to help manage active noninfectious uveitis, a condition where the eye becomes inflamed without an infection.

Investigated diseases

Noninfectious uveitis - This condition involves inflammation inside the eye that is not caused by an infection. The inflammation can affect different parts of the eye, such as the iris or the middle layer of the eye. It often occurs when the body's immune system mistakenly attacks healthy eye tissues. As the condition progresses, the inflammation can cause redness, pain, and blurred vision. It may also lead to the formation of small particles in the fluid inside the eye.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-521713-57-00Protocol codeR7041-NIU-24123Estimated enrolment29 patientsSponsorRegeneron Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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