Safety and Efficacy of Faricimab in Patients With NPDR

Non-Proliferative Diabetic Retinopathy Clinical Trial

— MAGIC  

Official title:

Faricimab for Retinal Non-Perfusion Associated With Non-Proliferative Diabetic Retinopathy: The MAGIC Phase 2, Multi-Center, Open-Label, Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05681884
• Other study ID #: ML43601
• Secondary ID: 164104
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 16, 2023
• Est. completion date: April 13, 2026

Study information

• Verified date: April 2024
• Source: Greater Houston Retina Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy.

Description:

Group 1: Subjects will be administered intravitreal faricimab every 4 through week 48 and then will be receive faricimab every 16 weeks with an end of study visit at week 96. At any visit after Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.

Group 2: Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab every 4 weeks from week 48 to week 92 with an end of study visit at week 96. At any visit before Week 48, if rescue criteria are met, faricimab will be given every 4 weeks and the subject will continue dosing through the end of the trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 13, 2026
• Est. primary completion date: March 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide signed IRB-approved informed consent form (ICF) prior to any study-specific procedures

• Willing and able to comply with clinic visits and study-related procedures and likely to return for all study visits, in the investigator's judgement

• Men or women > 18 years of age at the time of signing the Informed Consent Form

• Diagnosis of diabetes mellitus (type 1 or type 2)

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the final dose of study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (>12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

Contraception methods that do not result in a failure rate of < 1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable.

The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements of the study.

Ocular inclusion criteria for study eye:

Subjects must meet the following ocular inclusion criteria for the study eye for entry into the study:

• ETDRS BCVA > 20/400 in the study eye

• Non-proliferative diabetic retinopathy, as confirmed by the site investigator

• Substantial non-perfusion (defined as greater than 5 disc areas on Wide-Field Fluorescein Angiograph (WFFA)), as assessed by site investigator

Exclusion Criteria:

• Any known hypersensitivity to any of the components in the faricimab injection

• Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the site during the study

• Active cancer within the past 12 months prior to Screen/Baseline except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of =6 and a stable prostate-specific antigen for >12 months

• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Screen/Baseline

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab

o Women of childbearing potential must have a negative urine pregnancy test at the Screen/Baseline visit for both Group 1 and Group 2. Women of childbearing potential must also have a negative urine pregnancy test on any visit where they will receive treatment with IP or rescue medication. Urine pregnancy tests must be completed prior to the administration of IP/rescue medication and prior to FA being performed.

• Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Screen/Baseline, or during the course of this study

• Any prior or concomitant systemic anti-VEGF treatment within 4 months prior to Screen/Baseline

• Any use of any prohibited therapies during times of prohibition.

Ocular exclusion criteria for study eye:

Subjects who meet any of the following exclusion criteria for the study eye will be excluded from study entry:

• Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye within 4 months prior to Screen/Baseline

• SD-OCT central subfield thickness (CST) measurement > 325 µm, in the study eye due to DME.

• Evidence of infectious ocular infection, in the study eye at Screen/Baseline

• Any pan-retinal photocoagulation (PRP) treatment received in the study eye prior to Screen/Baseline

• Retinal vein occlusion in the study eye

• Cystoid macular edema not attributed to diabetes (instead caused by epiretinal membrane, macular telangiectasia, Coats disease, and inherited retinal diseases) in the study eye

• Current vitreous hemorrhage obscuring imaging in the study and/or dilated indirect examination

• Any intraocular surgery (e.g., cataract surgery) within 4 weeks prior to Screen/Baseline in the study eye

• Active intraocular inflammation including scleritis at screening/baseline

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Faricimab
Faricimab is a humanized bispecific antibody binding to human Ang-2 and VEGF. For Phase III studies, the Ro 686-7461 drug product is provided in single-dose 2-mL glass vials (6 mg/0.05 mL) with L-histidine/acetate buffered solution (approximately pH 5.5) containing sodium chloride, sucrose, L-methionine, polysorbate 20, and water for injection.

Locations

Country	Name	City	State
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Consultants of Texas	Beaumont	Texas
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Mississippi Retina Associates	Jackson	Mississippi
United States	Retina Consultants of Texas	Katy	Texas
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Retinal Consultants Medical Group	Modesto	California
United States	Florida Retina Institute	Orlando	Florida
United States	Retina Consultants of Minnesota St. Louis Park	Saint Louis Park	Minnesota
United States	Retina Consultants of Texas	San Antonio	Texas
United States	Retina Group of Florida	Sarasota	Florida
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	North Carolina Retina Associates	Wake Forest	North Carolina
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Long Island Vitreoretinal Consultants	Westbury	New York

Sponsors (2)

Lead Sponsor	Collaborator
Greater Houston Retina Research	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	Analyze the change in the area of retinal non-perfusion (RNP) within the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.	48 weeks
Primary	Primary Objective	Analyze the change in the area of retinal non-perfusion (RNP) outside the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.	48 weeks
Secondary	Change in area of RNP	Change in area of RNP, as assessed by a central reading center; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS	Baseline through week 96
Secondary	Change in area of RNP within the macula	Change in area of RNP within the macula, as assessed by ultrawide-field fluorescein; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS	Baseline through week 48 and from baseline through week 96
Secondary	Change in area of RNP outside of the macula	Change in area of RNP outside of the macula, as assessed by ultrawide-field fluorescein from baseline to week 96; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS	Baseline through week 48 and from baseline through week 96
Secondary	Percentage of subjects with disease	Percentage of subjects with neovascularization and/or vitreous hemorrhage and/or DME	Baseline through week 96
Secondary	Mean change in ETDRS	Mean change in ETDRS BCVA	Baseline through week 48 and from baseline through week 96
Secondary	Mean change in CST	Mean change in CST	Baseline through week 48 and from baseline through week 96
Secondary	Contrast Sensitivity	Contrast sensitivity as measured using the quantitative Contrast Sensitivity Function (qCSF) testing on the Manifold Contrast Vision	Baseline through Week 48 and from baseline through week 96
Secondary	Natural History of RNP	Natural history of RNP through detection of apoptosing retinal cells (DoARC) imaging	Baseline through Week 48 and from baseline through week 96
Secondary	2-step Improvement in DRSS	Proportion of subjects with at least a 2-step improvement in DRSS	48 weeks and 96 weeks