RO7200220 for Diabetic Macular Edema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Macular EdemaRO7200220 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, RO7200220, to see if it's more effective than ranibizumab alone in treating diabetic macular edema. The study will last 76 weeks.

Eligible Conditions
  • Diabetic Macular Edema

Treatment Effectiveness

Study Objectives

3 Primary · 30 Secondary · Reporting Duration: Baseline, Week 44 and Week 48

Week 48
Percentage of Participants with BCVA Letter Score ≤38 Letters (20/200 Snellen Equivalent) Over Time
Week 24
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Mean Change from Baseline in BCVA Letter Score Averaged Over Week 20 and Week 24 in Overall Enrolled Population
Mean Change from Baseline in BCVA Letter Score Averaged Over Week 20 and Week 24 in Previously Treated Participants
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 20 and Week 24 in Treatment-Naïve Participants
Baseline, Week 24
Change from Baseline in CST at Week 24
Mean Change from Baseline in Central Subfield Thickness (CST) at Week 24
Week 36
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Baseline, Week 36
Change from Baseline in CST at Week 36
Week 48
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatmentnaïve Participants
Baseline, Week 48
Change from Baseline in Central Subfield Thickness (CST) at Week 48
Week 48
Mean Change from Baseline in BCVA Letter Score Over Time
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Score Over Time
Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Score Over Time
Percentage of of Participants with BCVA Score ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Week 72
Mean Change from Baseline in BCVA Over Time
Mean Change from Baseline in CST Over Time
Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
Percentage of Participants with Absence of Diabetic Macular Edema Over Time
Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time
Percentage of of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Up to Week 72
Number of Participants with Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
Number of Participants with Abnormalities in Standard Ophthalmological Assessments
Number of Participants with Systemic and Ocular Adverse Events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B: Ranibizumab
1 of 2
Arm A: RO7200220 + Ranibizumab
1 of 2

Active Control

Experimental Treatment

230 Total Participants · 2 Treatment Groups

Primary Treatment: RO7200220 · No Placebo Group · Phase 2

Arm A: RO7200220 + RanibizumabExperimental Group · 2 Interventions: Ranibizumab, RO7200220 · Intervention Types: Drug, Drug
Arm B: RanibizumabActiveComparator Group · 2 Interventions: Ranibizumab, Sham Procedure · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 44 and week 48

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,362 Previous Clinical Trials
1,067,916 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,149 Previous Clinical Trials
876,006 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of diabetes mellitus (Type 1 or Type 2).
Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula.
You are able to provide written informed consent and to comply with the study protocol.