A Study to Evaluate the Efficacy and Safety of faricimab in Patients with Diabetic Macular Edema (RHINE)

Phase 1

• Conditions: Diabetic Macular Edema (DME); MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-005105-12-GB
• Lead Sponsor: F.Hoffmann La-Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

- Age >= 18 years
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
- Macular thickening secondary to DME involving the center of the fovea
- Documented BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

- Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- Uncontrolled blood pressure
- Pregnancy or breastfeeding, or intention to become pregnant during the study

Ocular Exclusion Criteria for Study Eye
- Treatment with panretinal photocoagulation within 3 months prior to Day 1 to the study eye
- Macular laser within 3 months prior to Day 1 to the study eye
- Any IVT or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
- Any use of medicated intraocular implants, including Ozurdex®, within 6 months of Day 1 and Iluvien® implants at any time prior to Day 1 to the study eye
- Prior administration of IVT faricimab in either eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified