A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

Conditions

• Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RO7446603 — DRUG
  Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
• Aflibercept — DRUG
  Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
• Faricimab — DRUG
  Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.

Study Details

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.

Key Dates

Start date

Jun 22, 2022

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

546 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Single Ascending Dose (SAD) Stage
  Participants received a single dose of RO7446603 at five different dose levels as IVT injection on Day 1.
• Experimental: Part 2: Multiple Dose (MD) Monotherapy Stage
  Participants received four different dose levels of RO7446603 (two doses at each planned dose level) as IVT injection, every 8 weeks (Q8W).
• Experimental: Part 3: MD Co-administration With Aflibercept Stage
  Participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W along with four doses of aflibercept IVT injections, every 4 weeks (Q4W).
• Experimental: Part 4: MD Co-administration With Faricimab Stage
  Participants received a single dose of faricimab followed by a 4-week enrichment screening period. Eligible participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W, along with three doses of faricimab (co-administered with RO7446603 or alone) as IVT injection, Q4W.
• Experimental: Part 5: MD Co-mixed With Faricimab Stage
  Participants will receive two different dose levels of RO7446603 (co-mixed with faricimab or faricimab alone) as IVT injection, Q4W for the first six doses followed by Q8W for four doses.

Primary Outcome Measure

Parts 1-5: Percentage of Participants With Adverse Events (AEs) [ Time Frame: From study start through end of study (Up to approximately 58 months) ]

Locations (69)

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