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RO7200220

Phase 1

Diabetic Macular Edema | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Jan 13, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

RO7200220 · 1 trial · 2 indications

Phase 1 1
NCT06771271A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular EdemaDiabetic Macular Edema
COMPLETED85 Analytics
PHASE1COMPLETED
A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
Diabetic Macular EdemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of Participants With Adverse Events (AEs)
Up to 18 weeks
Part 2: Number of Participants With Adverse Events (AEs)
Up to 24 weeks
Part 3: Number of Participants With Adverse Events (AEs)
Up to 20 weeks
Part 4: Number of Participants With Adverse Events (AEs)
Up to 36 weeks

Secondary Endpoints

Maximum Serum Concentration (Cmax)
Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Minimum Serum Concentration (Ctrough)
Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Time to Peak Serum Concentration (Tmax)
Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: RO7200220 MonotherapyEXPERIMENTALParticipants with DME received multiple ascending doses of RO7200220 (two doses at the assigned dose level), as intravitreal (IVT) injection, every 6 weeks (Q6W) in multiple cohorts.
Part 2: Expansion of RO7200220 MonotherapyEXPERIMENTALParticipants with DME who were anti-VEGF and corticosteroid IVT treatment-naive received three doses of RO7200220 monotherapy, as IVT injection, every 4 weeks (Q4W) in Part 2 cohorts.
Part 3: RO7200220 in Combination with RanibizumabEXPERIMENTALParticipants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3.
Part 4: RO7200220 MonotherapyEXPERIMENTALParticipants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts.

Interventions

NameTypeDescription
RO7200220DRUGRO7200220 was administered as IVT injection.
RanibizumabDRUGRanibizumab was administered as IVT injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: DME Participants: * Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association * Macular edema associated with DR defined as macular thickening by spectral domain optical coherence tomography (SD-OCT)...

Countries:United States
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Frequently asked questions about RO7200220

What is RO7200220 used for?

RO7200220 is an investigational small molecule being developed for diabetic macular edema, a condition that causes vision loss due to fluid buildup in the macula. It is also being studied for uveitic macular edema. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes RO7200220?

RO7200220 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials of the drug in the United States for diabetic macular edema and uveitic macular edema.

What phase is RO7200220 in?

RO7200220 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, but it remains investigational and has not received FDA approval. The drug is being studied for diabetic macular edema and uveitic macular edema.

What clinical trials is RO7200220 in?

RO7200220 has one completed clinical trial, NCT06771271, which investigated the drug as monotherapy and in combination with ranibizumab in participants with diabetic and uveitic macular edema. The study enrolled 85 participants in the United States and was Phase 1.

Is RO7200220 the same as ranibizumab?

No, RO7200220 is not the same as ranibizumab. RO7200220 is a small molecule being developed by Roche, while ranibizumab is a separate biologic therapy. In clinical trial NCT06771271, RO7200220 was studied as a monotherapy and in combination with ranibizumab.