New eye drug aims to stop diabetic vision loss
NCT ID NCT07588100
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times
Summary
This early-stage trial tests an experimental drug called RO7663498, given as an injection into the eye, for people with diabetic retinopathy. The main goal is to check safety and how the drug moves through the body. About 30 participants will receive multiple doses to see if it is well-tolerated.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7663498 (injected into the eye)
- What this could lead to
- If it works, this could point toward a new treatment to control diabetic retinopathy and prevent vision loss.
- What could go wrong
- This is a very early Phase 1 trial with only 30 people, focused on safety. It may not show any 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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- 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 years and older
- 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: General Inclusion Criteria * Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association Ocular Inclusion Criteria for the Study Eye * BCVA score at screening of \>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts * Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC) * Collection of \>= 90 micro liter (μL) AH deemed feasible and safe by the investigator. Exclusion Criteria: General Exclusion Criteria: * Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study. * History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically. Ocular Exclusion Criteria for the Study Eye * Center-involved Diabetic Macular Edema (DME) * Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below. * Vitreoretinal surgery/pars plana vitrectomy. * Any history of glaucoma surgery or planned glaucoma surgery during the study. * Uncontrolled glaucoma * Anterior segment neovascularization. * Vitreous or preretinal hemorrhage. * Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion. * Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \[SUN\] criteria \> 0 or National Eye Institute \[NEI\] vitreous haze grading \> 0) or any history of IOI. * Aphakia or previous violation of the posterior capsule in the study eye Ocular Exclusion Criteria for the Non-study Eye * BCVA \< 38 letters
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic retinopathy are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Global Research Management
RECRUITINGGlendale, California, 91204, United States
-
Ohio State Havener Eye Institute;Ophthalmology Research
RECRUITINGColumbus, Ohio, 43212, United States
-
University Retina and Macula Associates, PC
RECRUITINGOak Forest, Illinois, 60452, 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?
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Can a new gel make eye injections less painful?
- AI eye doctor: could software catch diabetic blindness sooner?
- Can eye scans reveal hidden clues about diabetes damage?
- AI could predict which eye treatments work best for Diabetes-Related vision loss