A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

NCT04853251 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: ML43000
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 50

Brief Summary

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy

  Baseline, Week 48

Secondary Outcomes (12)

• Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye

  Baseline, Week 24

• Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye

  Baseline, Week 24, Week 48

• Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye

  Baseline, Week 24, Week 48

• Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs

  Day 1 up to approximately Week 52

• Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs

  Day 1 to Week 52

Study Arms (1)

SUSVIMO

EXPERIMENTAL

Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres \[uL\] of the 100 milligrams/millilitres \[mg/ml\] formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.

Device: PDS Implant With Ranibizumab 100 mg/ml; Drug: LUCENTIS (Ranibizumab Injection)

Interventions

PDS Implant With Ranibizumab 100 mg/ml DEVICE

Ranibizumab 100 mg/mL will be delivered via PDS

SUSVIMO

LUCENTIS (Ranibizumab Injection) DRUG

Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.

SUSVIMO

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of nAMD prior to screening as determined by the investigator
• Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
• Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
• Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
• Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
• Overall decrease in nAMD disease activity detected on historical or screening OCT
• Stable or improved best-corrected visual acuity (BCVA)
• BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
• All subtypes of nAMD lesions are permissible
• nAMD lesions at the time of diagnosis must involve the macula
• Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images

You may not qualify if:

• Prior Ocular Treatment
• Study Eye:
• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
• Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
• Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
• History of corneal transplant
• History of conjunctival surgery in the superotemporal quadrant
• History of intraocular inflammation following anti-VEGF injection
• Either Eye:
• Previous PDS implantation
• Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
• Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
• Prior pars plana vitrectomy surgery
• Previous intraocular device implantation, excluding intraocular lenses
• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (50)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206-2747, United States

RECRUITING

California Retina Consultants

Bakersfield, California, 93309, United States

COMPLETED

Retina Associates of Southern California

Huntington Beach, California, 92647, United States

RECRUITING

California Eye Specialists Medical group Inc.

Pasadena, California, 91107-3747, United States

COMPLETED

Retinal Consultants Med Group

Sacramento, California, 95841-2013, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158-2510, United States

RECRUITING

Orange County Retina Med Group

Santa Ana, California, 92705-6504, United States

RECRUITING

Macula Retina Vitreous Research Institute

Torrance, California, 90503-3270, United States

RECRUITING

Southwest Retina Consultants

Durango, Colorado, 81303, United States

COMPLETED

Advanced Vision Research Institute

Longmont, Colorado, 80503-6499, United States

RECRUITING

Retina Group of New England

Waterford, Connecticut, 06385-1215, United States

WITHDRAWN

Retina Specialty Institute

Pensacola, Florida, 32503-2030, United States

RECRUITING

Ft Lauderdale Eye Institute

Plantation, Florida, 33324-3118, United States

WITHDRAWN

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711-1141, United States

RECRUITING

Southeast Retina Center

Augusta, Georgia, 30909-6440, United States

RECRUITING

University Retina and Macula Associates, PC

Lemont, Illinois, 60439-7421, United States

RECRUITING

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

WITHDRAWN

Retina Associates of Kentucky

Lexington, Kentucky, 40509-1827, United States

WITHDRAWN

Maine Eye Center

Portland, Maine, 04101, United States

RECRUITING

The Retina Care Center

Baltimore, Maryland, 21209-2219, United States

RECRUITING

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, 21287-0005, United States

RECRUITING

Retina Group of Washington

Chevy Chase, Maryland, 20815-6956, United States

WITHDRAWN

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

COMPLETED

Associated Retinal Consultants PC

Royal Oak, Michigan, 48073, United States

RECRUITING

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, 55435-3004, United States

RECRUITING

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017-5065, United States

COMPLETED

Sierra Eye Associates

Reno, Nevada, 89502-1605, United States

RECRUITING

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

RECRUITING

Seeta Eye Centers

Poughkeepsie, New York, 12603-2416, United States

RECRUITING

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803-2493, United States

WITHDRAWN

Duke Eye Center

Durham, North Carolina, 27705-4699, United States

RECRUITING

Fargo Retina Consultants

Fargo, North Dakota, 58047, United States

RECRUITING

Cincinnati Eye Institute

Blue Ash, Ohio, 45242-5537, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Tulsa Retina Consultants

Tulsa, Oklahoma, 74114, United States

WITHDRAWN

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107-5109, United States

WITHDRAWN

Palmetto Retina Center

Florence, South Carolina, 29501, United States

WITHDRAWN

Palmetto Retina Center, LLC

West Columbia, South Carolina, 29169-2429, United States

WITHDRAWN

Charles Retina Institute

Germantown, Tennessee, 38138-2405, United States

RECRUITING

Tennessee Retina PC

Nashville, Tennessee, 37203-1596, United States

RECRUITING

Panhandle Eye Group LLP Southwest Retina Specialists

Amarillo, Texas, 79106-1835, United States

COMPLETED

Austin Retina Associates

Austin, Texas, 78705-1169, United States

WITHDRAWN

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

Retina Consultants of Texas

Schertz, Texas, 78154, United States

RECRUITING

Retina Associates of Utah, PLLC

Salt Lake City, Utah, 84107-6767, United States

RECRUITING

Piedmont Eye Center

Lynchburg, Virginia, 24502-4271, United States

RECRUITING

Wagner Kapoor Institute

Norfolk, Virginia, 23502-3933, United States

RECRUITING

Retina Institute of Virginia

Richmond, Virginia, 23235-1962, United States

WITHDRAWN

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: ML43000 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: The BVCA examiner will be masked as best as possible to participant study eye assignment and study visit type.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (50)