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RECRUITING

NCT04108156

PHASE3

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

Official title: A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

634

Start Date

2019-09-30

Completion Date

2027-11-16

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Diabetic Macular Edema

Interventions

DRUG

PDS Implant Pre-Filled with 100 mg/mL Ranibizumab

Will be administered as per the schedule described in individual arm.

DRUG

Intravitreal Ranibizumab 0.5 mg Injection

Will be administered as per the schedule described in individual arm.

DRUG

Ranibizumab refill exchange

Will be administered as per the schedule described in individual arm.

Inclusion Criteria: * Age ≥18 years at time of signing informed consent form (ICF) * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening Study eye * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening * BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent) Exclusion Criteria: * High-risk PDR * Active intraocular inflammation (grade trace or above) * Suspected or active ocular or periocular infection of either eye * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * Cerebrovascular accident or myocardial infarction within 6 months prior to randomization * Atrial fibrillation diagnosis or worsening within 6 months prior to randomization * Uncontrolled blood pressure Substudy: Inclusion Criteria: * Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center Exclusion Criteria (Cohort 1 Only): * Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications * Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer * Current systemic treatment for a confirmed active systemic infection * Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment * Use of antimitotic or antimetabolite therapy within 30 days Ocular Exclusion Criteria for Study Eye: * Any ocular condition that may render the participant at high risk for surgical or treatment complications * Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit * Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit * Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss * Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant * Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye * Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis) * Any history of uveitis * Active blepharitis

Locations (92)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Retinal Consultants of Arizona;Opthalmology

Phoenix, Arizona, United States

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

The Retina Partners

Encino, California, United States

Retina Consultants of Orange County;Clinical Research

Fullerton, California, United States

Jules Stein Eye Institute/ UCLA

Los Angeles, California, United States

Northern California Retina-Vitreous Associates

Mountain View, California, United States

East Bay Retina Consultants

Oakland, California, United States

Doheny Eye Institute

Pasadena, California, United States

California Eye Specialists Medical Group

Pasadena, California, United States

Retina Consultants Medical Group

Sacramento, California, United States

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Orange County Retina Medical Group

Santa Ana, California, United States

California Retina Consultants;Research Department

Santa Barbara, California, United States

Eye Center of Northern Colorado

Fort Collins, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Retina Group of Florida

Fort Lauderdale, Florida, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Southern Vitreoretinal Associates;Research

Tallahassee, Florida, United States

Retina Associates of Florida;Retina Associates of Florida

Tampa, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

Georgia Retina

Marietta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Illinois Retina Associates

Joliet, Illinois, United States

University Retina

Lemont, Illinois, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Retina Associates

Lenexa, Kansas, United States

Retina & Vitreous Associates of Kentucky

Lexington, Kentucky, United States

Maine Eye Center

Portland, Maine, United States

The Retina Care Center

Baltimore, Maryland, United States

Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst

Baltimore, Maryland, United States

The Retina Group of Washington;Retinal Disease

Chevy Chase, Maryland, United States

Cumberland Valley Retina Consultants;Clinical Research

Hagerstown, Maryland, United States

Retina Specialist

Towson, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Vitreo Retinal Associates

Worcester, Massachusetts, United States

Retina Specialists Of Michigan

Grand Rapids, Michigan, United States

Associated Retinal Consultants - Royal Oak

Royal Oak, Michigan, United States

VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota

Minneapolis, Minnesota, United States

Pepose Vision Institute

Chesterfield, Missouri, United States

Retina Institute

St Louis, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Retina Associates of New Jersey

Teaneck, New Jersey, United States

Long Island Vitreoretinal Consultants;Opthalmology

Great Neck, New York, United States

Retina Vitreous Surgeons of Central New York

Liverpool, New York, United States

New York University (NYU)

New York, New York, United States

Ophthalmic Consultants of Long Island

Oceanside, New York, United States

Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research

Asheville, North Carolina, United States

Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina

Charlotte, North Carolina, United States

Duke Eye Center

Durham, North Carolina, United States

Graystone Eye;Clinical Research

Hickory, North Carolina, United States

Cape Fear Retinal Associates

Wilmington, North Carolina, United States

Cincinnati Eye Institute;Retina

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State Havener Eye Institute;Ophthalmology Research

Columbus, Ohio, United States

Midwest Retina;Retina/Vitreous

Dublin, Ohio, United States

Retina Vitreous Center - Glen Eagles

Edmond, Oklahoma, United States

Retina Northwest;Research Department

Portland, Oregon, United States

Cumberland Valley Retina Consultants

Chambersburg, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Charleston Neuroscience

Ladson, South Carolina, United States

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Charles Retina Institution;Retina surgery

Germantown, Tennessee, United States

Tennessee Retina

Nashville, Tennessee, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Texas Retina Associates

Arlington, Texas, United States

Austin Research Center for Retina

Austin, Texas, United States

Austin Retina Associates;Opthalmology

Austin, Texas, United States

Austin Clinical Research, LLC

Austin, Texas, United States

Retina & Vitreous of Texas

Bellaire, Texas, United States

Texas Retina Associates;Research

Dallas, Texas, United States

Texas Retina Associates

Fort Worth, Texas, United States

Retina Consultants of Texas

Houston, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Rocky Mountain Retina Consultants

Murray, Utah, United States

Retina Associates of Utah, PLLC;Clinical Research

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Institute;Opthalmology

Norfolk, Virginia, United States

Retina Institute of Virginia

Richmond, Virginia, United States

Pacific Northwest Retina

Silverdale, Washington, United States

Spokane Eye Clinical Research;Spokane Eye Surgery Center

Spokane, Washington, United States

Clinical Research Directory

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (92)