A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema

NCT02699450 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: BP30099RG7716
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 60

Brief Summary

This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants

  Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.

  Baseline, Week 24

Secondary Outcomes (45)

• Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated Participants

  Baseline, Week 24

• Mean Change From Baseline in BCVA Letter Score at Week 24, in All Participants

  Baseline, Week 24

• Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants

  Baseline, Week 24

• Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants

  Baseline up to Week 24

• Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants

  Baseline up to Week 24

Study Arms (3)

Arm A: 0.3 mg Ranibizumab

ACTIVE COMPARATOR

Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Drug: Ranibizumab

Arm B: 1.5 mg Faricimab

EXPERIMENTAL

Participants will receive 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Drug: Faricimab

Arm C: 6 mg Faricimab

EXPERIMENTAL

Participants will receive 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.

Drug: Faricimab

Interventions

Faricimab DRUG

Faricimab will be administered by IVT injection in the study eye.

Also known as: RO6867461, RG7716

Arm B: 1.5 mg Faricimab; Arm C: 6 mg Faricimab

Ranibizumab DRUG

Ranibizumab will be administered by IVT injection in the study eye.

Also known as: Lucentis

Arm A: 0.3 mg Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Macular edema associated with diabetic retinopathy
• Decreased visual acuity attributable primarily to DME
• Diagnosis of diabetes mellitus

You may not qualify if:

• High risk proliferative diabetic retinopathy
• Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
• Uncontrolled glaucoma
• Current or history of ocular disease in the study eye other than DME
• Major illness or major surgical procedure within 1 month prior to Day 1
• Uncontrolled blood pressure
• Glycosylated hemoglobin (HbA1c) greater than (\>) 12 percent (%) at screening
• Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (60)

Retinal Research Institute, LLC

Phoenix, Arizona, 85014, United States

Location

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85021, United States

Location

Retina Associates Southwest PC

Tucson, Arizona, 85750, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

United Med Res Inst

Inglewood, California, 90301, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Ophthalmic Clinical Trials San Diego

Oceanside, California, 92056, United States

Location

Southern CA Desert Retina Cons

Palm Desert, California, 92211, United States

Location

Retina Consultants, San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Southern

Colorado Springs, Colorado, 80909, United States

Location

Rand Eye

Deerfield Beach, Florida, 33064, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Retina Vitreous Assoc of FL

St. Petersburg, Florida, 33711, United States

Location

Southern Vitreoretinal Assoc

Tallahassee, Florida, 32308, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

Univ of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Illinois Retina Associates SC

Oak Park, Illinois, 60304, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49546, United States

Location

Vitreoretinal Surgery

Edina, Minnesota, 55435, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Center of New Jersey

Bloomfield, New Jersey, 07003, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Capital Region Retina

Albany, New York, 12206, United States

Location

Opthalmic Consultants of LI

Lynbrook, New York, 11563, United States

Location

Retina Consultants of Western New York

Orchard Park, New York, 14127, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Cleveland Clinic Foundation; Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

OSU Eye Physicians & Surgeons

Columbus, Ohio, 43212, United States

Location

Oregon Retina, LLP

Eugene, Oregon, 97401, United States

Location

Retina Northwest

Portland, Oregon, 97221, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Charleston Neuroscience Inst

Ladson, South Carolina, 29456, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Tennessee Retina PC.

Nashville, Tennessee, 37203, United States

Location

W Texas Retina Consultants PA

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Austin

Austin, Texas, 78705, United States

Location

Retina Specialists

DeSoto, Texas, 75115, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Med Center Ophthalmology Assoc

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

Univ of Virginia Ophthalmology

Charlottesville, Virginia, 22903, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

West Virginia University Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Sahni J, Patel SS, Dugel PU, Khanani AM, Jhaveri CD, Wykoff CC, Hershberger VS, Pauly-Evers M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Osborne A, Weikert R, Fauser S. Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Ophthalmology. 2019 Aug;126(8):1155-1170. doi: 10.1016/j.ophtha.2019.03.023. Epub 2019 Mar 21.

  PMID: 30905643 DERIVED

MeSH Terms

Interventions

faricimab; Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: April 27, 2016
• Primary Completion: September 15, 2017
• Study Completion: December 14, 2017
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-08

Locations

US (60)