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RG7774

Phase 2

Diabetic Retinopathy | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Sep 25, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

RG7774 · 1 trial · 1 indication

Phase 2 1
NCT04265261A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic RetinopathyDiabetic Retinopathy
COMPLETED139 Analytics
PHASE2COMPLETED
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
Diabetic RetinopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye
Week 36

The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy)

Percentage of Participants With Adverse Events (AEs)
Up to 1 year (baseline through follow-up period)

Secondary Endpoints

Time-to-Event for Vision-Threatening DR in the Study Eye
Up to Day 277
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye
Week 36
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
Baseline; Week 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group APLACEBO_COMPARATORParticipants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Group BEXPERIMENTALParticipants will receive a low oral dose of RG7774 QD
Group CEXPERIMENTALParticipants will receive a high oral dose of RG7774 QD

Interventions

NameTypeDescription
PlaceboDRUGParticipants will receive oral placebo matched to RG7774
RG7774DRUGParticipants will receive oral RG7774
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria * Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations * Male and female patients of at least 18 years of age * Treatment naïve with moderately severe to sever...

Countries:United StatesAustraliaPolandPuerto RicoSlovakiaSpainUnited Kingdom
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Frequently asked questions about RG7774

What is RG7774 used for?

RG7774 is an investigational small molecule being developed for diabetic retinopathy, a complication of diabetes that affects the eyes. It is being studied in patients with diabetes mellitus type 1 or type 2 who have treatment-naive diabetic retinopathy. The drug is currently in Phase 2 clinical development.

Who makes RG7774?

RG7774 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of RG7774 in patients with diabetic retinopathy.

What phase is RG7774 in?

RG7774 is in Phase 2 clinical development. A Phase 2 study of RG7774 has been completed, which evaluated the drug's efficacy and safety in patients with diabetes mellitus type 1 or type 2 with treatment-naive diabetic retinopathy. The drug is not yet approved and remains investigational.

What clinical trials is RG7774 in?

RG7774 has one completed Phase 2 clinical trial registered under NCT04265261. The study investigated the efficacy and safety of RG7774 in patients with diabetes mellitus type 1 or type 2 with treatment-naive diabetic retinopathy. The trial enrolled 139 participants across the United States, Australia, Poland, Puerto Rico, Slovakia, Spain, and the United Kingdom.

Is RG7774 FDA approved?

RG7774 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for diabetic retinopathy. A Phase 2 clinical trial has been completed, but the drug has not yet received regulatory approval for any use.