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RO7663498

Phase 1

Diabetic Retinopathy | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

RO7663498 · 1 trial · 1 indication

Phase 1 1
NCT07588100A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic RetinopathyDiabetic Retinopathy
RECRUITING30 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy
Diabetic RetinopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Ocular Adverse Events (AEs)
Up to Week 20
Percentage of Participants With Systemic (non-ocular) AEs
Up to Week 20
Number of Abnormalities Recorded in Standard Ophthalmological Assessments
Up to Week 20

Secondary Endpoints

Aqueous Humor (AH) Concentrations of RO7663498
Up to Week 12
Serum Concentrations of RO7663498
Up to Week 20
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParticipants will receive RO7663498.
Cohort 2EXPERIMENTALParticipants will receive RO7663498.
Cohort 3EXPERIMENTALParticipants will receive RO7663498.
Cohort 4EXPERIMENTALParticipants will receive RO7663498.

Interventions

NameTypeDescription
RO7663498DRUGParticipants will receive RO7663498 as per the schedule defined in the protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 Ear...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT07588100lastUpdatePostDate: changed
LOWAug 17, 2026NCT07588100lastUpdatePostDate: changed

Frequently asked questions about RO7663498

What is RO7663498 used for in diabetic retinopathy?

RO7663498 is an investigational small molecule being studied for the treatment of diabetic retinopathy, a complication of diabetes that affects the eyes. It is administered via intravitreal injection directly into the eye. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RO7663498?

RO7663498 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug in patients with diabetic retinopathy.

What phase is RO7663498 in?

RO7663498 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug following intravitreal administration in participants with diabetic retinopathy. The study is currently recruiting participants and has not yet progressed to later-phase trials.

What clinical trials is RO7663498 in?

RO7663498 is being evaluated in a single Phase 1 clinical trial registered as NCT07588100. This study is investigating the safety, tolerability, and pharmacokinetics of RO7663498 following intravitreal administration in participants with diabetic retinopathy. The trial is currently recruiting participants in the United States and aims to enroll 30 patients aged 18 years and older.

How is RO7663498 administered?

RO7663498 is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for ophthalmic drugs to deliver the medication locally to the retina. The ongoing Phase 1 trial is evaluating this delivery method in patients with diabetic retinopathy.