Gene therapy shot aims to cut eye injections for diabetic vision loss
NCT ID NCT05930561
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This phase 2 trial tests a gene therapy called 4D-150 for diabetic macular edema, a condition that causes vision loss in people with diabetes. The study involves 72 adults who will receive either the gene therapy or standard aflibercept injections. The goal is to see if a single dose of gene therapy can reduce the need for frequent eye injections over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 4D-150 gene therapy
- What this could lead to
- If successful, this gene therapy could reduce the number of eye injections needed to control diabetic macular edema, potentially improving quality of life.
- What could go wrong
- This is an early phase 2 trial with only 72 participants. The therapy may not work as hoped, and there are risks from the injection and gene therapy itself.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * ≥18 years of age * Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; diagnosis of DME must be within 2 years of Screening * CST ≥ 350 μm (Spectralis SD-OCT) in the study eye at Screening, confirmed by the independent reading center * Demonstrate clinical response to on-study aflibercept injection in the study eye. * Decreased visual acuity attributable primarily to DME * BCVA in the study eye between 25 and 83 ETDRS letters, inclusive (\~20/320 and 20/25, respectively) at Screening * Study eye amenable to IVT injection * Sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures * Provide written informed consent Exclusion Criteria: * Macular edema in the study eye considered to be secondary to a cause other than DME * Systemic anti-VEGF treatment (e.g. sunitinib, bevacizumab, pazopanib) within 6 months, or anticipated need for systemic anti-VEGF therapy during study participation * Systemic corticosteroids (oral, intravenous, intramuscular, intra-articular) or other immunosuppressive medications within 3 months * Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to 4D-150 administration (Day 1) * Prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy in either eye * Any concurrent ocular condition in the study eye that is likely to require surgical intervention (e.g. cataract surgery) during the 2 year (104 week) study duration Note: Other inclusion/exclusion criteria apply.
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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
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Austin Clinical Research
Austin, Texas, 78750, United States
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Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
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Emanuelli Research and Development Center
Arecibo, Puerto Rico, X00612, Puerto Rico
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Erie Retina Research
Erie, Pennsylvania, 16507, United States
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Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
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Verum Research, LLC
Eugene, Oregon, 97401, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a work health check catch diabetic eye damage before it steals sight?
- The 20-Minute squeeze: how eye injections push pressure up
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Could years of eye injections weigh down the upper eyelid?
- Eye implant takes aim at diabetic macular edema
- Can a single gene therapy injection ease diabetic macular edema?