Study of the safety, tolerability, processing by the body, and ability to provoke immune system response of ocular injections of RO7446603 alone and in combination with aflibercept or faricimab in participants with diabetic macular edema

Phase 1

• Conditions: Diabetic macular edema (DME); Eye Diseases

• Registration Number: ISRCTN14152148
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-20
• Last Update Posted: 19 December 2023
• Study Completion: 2024-09-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Age =18 years at the time of signing the Informed Consent Form
2. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
3. Macular thickening secondary to DME involving the center of the fovea
4. Decreased visual acuity attributable primarily to DME

Exclusion Criteria

Current exclusion criteria as of 08/08/2023:

1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
2. Uncontrolled blood pressure (BP), defined as systolic >180 millimetres of mercury (mmHg) and /or diastolic >100 mmHg while the participants is at rest
3. Pregnancy or breastfeeding, or intention to become pregnant during the study
4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1
5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1
6. High-risk proliferative diabetic retinopathy (PDR) in the study eye
7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
9. Other protocol-specified inclusion/exclusion criteria may apply

_____

Previous exclusion criteria:

1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
2. Uncontrolled blood pressure (BP), defined as systolic >180 mmHg and/or diastolic >100 mmHg while the participants is at rest
3. Pregnancy or breastfeeding, or intention to become pregnant during the study
4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1
5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1
6. High-risk proliferative diabetic retinopathy (PDR) in the study eye
7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
9. Other protocol-specified inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified