Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration

NCT ID: NCT03038880

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-27
• Study Completion Date: 2018-03-29

Brief Summary

This was a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to investigate the efficacy, safety and pharmacokinetics of faricimab (RO6867461; RG7716) administered with extended dosing regimens in treatment-naive participants with neovascular age related macular degeneration (nAMD). Only one eye was chosen as the study eye.

Conditions

Neovascularization, Choroidal; Macular Degeneration, Age-Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

6 mg Faricimab Q12W

6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).

Group Type: EXPERIMENTAL

Faricimab

Intervention Type: DRUG

Faricimab was administered via IVT injections as specified during the treatment period.

Sham Procedure

Intervention Type: DRUG

The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.

6 mg Faricimab Q16W

6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.

Group Type: EXPERIMENTAL

Faricimab

Intervention Type: DRUG

Faricimab was administered via IVT injections as specified during the treatment period.

Sham Procedure

Intervention Type: DRUG

The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.

0.5 mg Ranibizumab Q4W

0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Ranibizumab was administered via IVT injections as specified during the treatment period.

Interventions

Faricimab

Faricimab was administered via IVT injections as specified during the treatment period.

Intervention Type: DRUG

Ranibizumab

Ranibizumab was administered via IVT injections as specified during the treatment period.

Intervention Type: DRUG

Sham Procedure

The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.

Intervention Type: DRUG

Other Intervention Names

RO6867461; RG7716; Lucentis®

Eligibility Criteria

Inclusion Criteria

• Treatment-naive CNV secondary to AMD (nAMD)
• Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity by fundus fluorescein angiography (FFA) or spectral-domain optical coherence tomography (SD-OCT; as evidenced by subretinal fluid, subretinal hyperreflective material, evidence of leakage, or hemorrhage)
• CNV lesion of all types with: total lesion size (including blood, atrophy, fibrosis, and neovascularization) of 6 disc areas or less by FFA; and CNV component area of at least 50% of total lesion size by FFA; and active CNV confirmed by FFA (evidence of leakage); and CNV exudation confirmed by SD-OCT (presence of fluid)
• BCVA letter score of 73 to 24 letters (inclusive) on ETDRS-like charts (20/40-20/320 Snellen equivalent) on day 1
• Clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis

Exclusion Criteria

• CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
• Central serous chorioretinopathy at screening
• Retinal pigment epithelial tear involving the macula
• On FFA: subretinal hemorrhage, fibrosis, or atrophy of more than (>)50% of the total lesion area and/or that involves the fovea
• Any prior or concomitant treatment for CNV including (but not restricted to) IVT treatment (steroids, anti-VEGF, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or surgical intervention
• Cataract surgery within 3 months of baseline assessments
• Any other intraocular surgery (pars plana vitrectomy, glaucoma surgery, corneal transplant, radiotherapy)
• Prior IVT treatment (including anti-VEGF medication) except for management of cataract complication with steroid IVT treatment
• Prior periocular pharmacological intervention for other retinal diseases
• Any concurrent intraocular condition in the study eye (eg, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the course of the study
• Active intraocular inflammation (grade trace or above) in the study eye on day 1 (before randomization)
• Current vitreous hemorrhage in the study eye
• Uncontrolled glaucoma (eg, progressive loss of visual fields or defined as IOP ≥25 mm Hg despite treatment with antiglaucoma medication) in the study eye
• Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye on day 1 (before randomization)
• Any major illness or major surgical procedure within 1 month before screening
• Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >100 mm Hg while participant at rest). If a participant's initial reading exceeded these values, a second reading was taken later on the same day, or on another day during the screening period. If the participant's blood pressure was controlled by antihypertensive medication, the participant was taking the same medication continuously for at least 30 days before day 1
• Stroke or myocardial infarction within 3 months before day 1
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
• Pregnant or breastfeeding, or intended to become pregnant during the study
• Known hypersensitivity to ranibizumab, fluorescein, any ingredients of the formulation used, dilating eye drops, or any of the anesthetic and antimicrobial drops used
• Treatment with investigational therapy within 3 months before initiation of study treatment

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Retina Associates Southwest PC

Tucson, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retinal Diagnostic Center

Campbell, California, United States

Retina Consultants of Southern Colorado PC; Clinical Research Department

Colorado Springs, Colorado, United States

Rand Eye

Deerfield Beach, Florida, United States

Florida Eye Associates

Melbourne, Florida, United States

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

The Retina Care Center

Baltimore, Maryland, United States

Vitreo Retinal Surgery

Minneapolis, Minnesota, United States

Sierra Eye Associates

Reno, Nevada, United States

Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Vitreoretinal Consultants

Great Neck, New York, United States

Oregon Retina, LLP

Eugene, Oregon, United States

Retina Northwest

Portland, Oregon, United States

Charles Retina Institute

Germantown, Tennessee, United States

Retina Res Institute of Texas

Abilene, Texas, United States

Texas Retina Associates

Arlington, Texas, United States

Retina Research Center

Austin, Texas, United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Retina Associates of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699.

Reference Type: DERIVED

PMID: 32729897 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR39521

Identifier Type: -

Identifier Source: org_study_id