RECRUITING

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

Conditions

Neovascular Age-related Macular Degeneration

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase IV, Multicenter, Open-Label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)

Quick Facts

Study Start:2021-12-14

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04853251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Initial diagnosis of nAMD within 18 months prior to screening * 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) imaging prior to the first anti-vascular endothelial growth factor (VEGF) intravitreal therapy (IVT) treatment for nAMD * Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD * Demonstrated response to at least two anti-VEGF IVT injections since diagnosis, as evidenced by the following: * Overall decrease in nAMD disease activity detected on historical or screening OCT as assessed by the investigator and confirmed by the central reading center AND * Stable or improved BCVA * Best-corrected visual acuity (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 (6 millimetres (mm) diameter centered at the fovea) * 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 * Prior treatment with verteporfin for injection, external-beam radiation therapy, or transpupillary thermotherapy * Previous treatment with corticosteroid IVT injection * Previous laser (any type) used for age related macular degeneration (AMD) treatment * History of vitreous hemorrhage * History of rhegmatogenous retinal detachment * History of corneal transplant * History of conjunctival surgery in the superotemporal quadrant * Previous PDS implantation * Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment * Prior pars plana vitrectomy surgery * Previous intraocular device implantation excluding intraocular lenses * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening * Contact lens wear in either eye within 2 months of screening * Any prior ocular trauma (blunt or penetrating) * History of corneal transplantation, including partial-thickness corneal grafts * Prior treatment with brolucizumab * Prior treatment with any anti-VEGF biosimilar agents within 2 months of screening * Prior treatment with faricimab within 2 months of screening * Prior treatment with aflibercept 8 mg within 2 months of screening * Prior treatment with external-beam radiation therapy or brachytherapy * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area (1.27 square millimitres (mm\^2)) in size at screening * Subfoveal fibrosis or subfoveal atrophy * Retinal pigment epithelial tear * Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment * Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus exam * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery * Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia * Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery * Uncontrolled ocular hypertension or glaucoma * Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification) * Conjunctival pathologies in the superotemporal quadrant * History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis * Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure * Trichiasis * Corneal neuropathy * Lagophthalmos or incomplete blink • Active or history of facial nerve palsy/paresis * Aphakia or absence of the posterior capsule * Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results * Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center * Fuchs endothelial corneal dystrophy Grade ≥ 2 * Previous corneal endothelial cell damage, including from blunt or surgical trauma * Any ocular condition that precludes obtaining an analyzable specular microscopy image * Active or history of corneal edema * Active or history of corneal dystrophies * Active or history of iridocorneal endothelial syndrome * Active or history of pseudoexfoliation syndrome * Active or history of herpetic keratitis or kerato-uveitis * Any active or history of uveitis * Active or history of keratitis, scleritis, or endophthalmitis * Active ocular or periocular infection * Active or history of Sjogren's syndrome or keratoconjunctivitis sicca * Active or history of floppy eyelid syndrome * Active or history of chronic eye rubbing * Active thyroid eye disease * Uncontrolled blood pressure * Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's), etc. * History of stroke within the last 3 months prior to screening * Uncontrolled atrial fibrillation within 3 months of screening * History of myocardial infarction within the last 3 months prior to screening * History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator * Current active systemic infection * Use of any systemic anti-VEGF agents * Chronic use of oral corticosteroids * Active cancer within 12 months of enrollment 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 * Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals) * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit * Pregnant or breastfeeding, or intention to become pregnant during the study * Women of childbearing potential, must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Initial diagnosis of nAMD within 18 months prior to screening
* 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) imaging prior to the first anti-vascular endothelial growth factor (VEGF) intravitreal therapy (IVT) treatment for nAMD
* Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD
* Demonstrated response to at least two anti-VEGF IVT injections since diagnosis, as evidenced by the following:
* Overall decrease in nAMD disease activity detected on historical or screening OCT as assessed by the investigator and confirmed by the central reading center AND
* Stable or improved BCVA
* Best-corrected visual acuity (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 (6 millimetres (mm) diameter centered at the fovea)
* 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
* Prior treatment with verteporfin for injection, external-beam radiation therapy, or transpupillary thermotherapy
* Previous treatment with corticosteroid IVT injection
* Previous laser (any type) used for age related macular degeneration (AMD) treatment
* History of vitreous hemorrhage
* History of rhegmatogenous retinal detachment
* History of corneal transplant
* History of conjunctival surgery in the superotemporal quadrant
* Previous PDS implantation
* Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
* Prior pars plana vitrectomy surgery
* Previous intraocular device implantation excluding intraocular lenses
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
* Contact lens wear in either eye within 2 months of screening
* Any prior ocular trauma (blunt or penetrating)
* History of corneal transplantation, including partial-thickness corneal grafts
* Prior treatment with brolucizumab
* Prior treatment with any anti-VEGF biosimilar agents within 2 months of screening
* Prior treatment with faricimab within 2 months of screening
* Prior treatment with aflibercept 8 mg within 2 months of screening
* Prior treatment with external-beam radiation therapy or brachytherapy
* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area (1.27 square millimitres (mm\^2)) in size at screening
* Subfoveal fibrosis or subfoveal atrophy
* Retinal pigment epithelial tear
* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus exam
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
* Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
* Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery
* Uncontrolled ocular hypertension or glaucoma
* Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
* Conjunctival pathologies in the superotemporal quadrant
* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
* Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
* Trichiasis
* Corneal neuropathy
* Lagophthalmos or incomplete blink • Active or history of facial nerve palsy/paresis
* Aphakia or absence of the posterior capsule
* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
* Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center
* Fuchs endothelial corneal dystrophy Grade ≥ 2
* Previous corneal endothelial cell damage, including from blunt or surgical trauma
* Any ocular condition that precludes obtaining an analyzable specular microscopy image
* Active or history of corneal edema
* Active or history of corneal dystrophies
* Active or history of iridocorneal endothelial syndrome
* Active or history of pseudoexfoliation syndrome
* Active or history of herpetic keratitis or kerato-uveitis
* Any active or history of uveitis
* Active or history of keratitis, scleritis, or endophthalmitis
* Active ocular or periocular infection
* Active or history of Sjogren's syndrome or keratoconjunctivitis sicca
* Active or history of floppy eyelid syndrome
* Active or history of chronic eye rubbing
* Active thyroid eye disease
* Uncontrolled blood pressure
* Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's), etc.
* History of stroke within the last 3 months prior to screening
* Uncontrolled atrial fibrillation within 3 months of screening
* History of myocardial infarction within the last 3 months prior to screening
* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator
* Current active systemic infection
* Use of any systemic anti-VEGF agents
* Chronic use of oral corticosteroids
* Active cancer within 12 months of enrollment 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
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit
* Pregnant or breastfeeding, or intention to become pregnant during the study
* Women of childbearing potential, must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

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

CONTACT

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Genetech

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206

United States

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85016

United States

California Retina Consultants.

Bakersfield, California, 93309

United States

California Eye Specialists Medical group Inc.

Pasadena, California, 91107

United States

Retinal Consultants Med Group

Sacramento, California, 95825

United States

Orange County Retina Med Group

Santa Ana, California, 92705

United States

Macula Retina Vitreous Center

Torrance, California, 90503-3270

United States

Southwest Retina Consultants

Durango, Colorado, 81303

United States

Colorado Retina Associates, PC

Lakewood, Colorado, 80228

United States

Advanced Vision Research Institute

Longmont, Colorado, 80503-6499

United States

Retina Group of New England

Waterford, Connecticut, 06385

United States

Ft Lauderdale Eye Institute

Miami Lakes, Florida, 33016

United States

Retina Specialty Institute

Pensacola, Florida, 32503

United States

Retina Vitreous Associates of Florida

Saint Petersburg, Florida, 33711-1141

United States

Southeast Retina Center

Augusta, Georgia, 30909

United States

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452

United States

Wolfe Eye Clinic

West Des Moines, Iowa, 50266

United States

Retina Associates of Kentucky

Lexington, Kentucky, 40509

United States

Maine Eye Center

Portland, Maine, 04101

United States

The Retina Care Center

Baltimore, Maryland, 21209

United States

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, 21287-0005

United States

Retina Group of Washington

Chevy Chase, Maryland, 20815

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740

United States

Associated Retinal Consultants PC

Royal Oak, Michigan, 48073

United States

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

Edina, Minnesota, 55435

United States

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017

United States

Sierra Eye Associates

Reno, Nevada, 89502

United States

Envision Ocular, LLC

Bloomfield, New Jersey, 07003

United States

Mid Atlantic Retina

Cherry Hill, New Jersey, 08034

United States

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803

United States

Cincinnati Eye Institute

Cincinnati, Ohio, 45242

United States

Erie Retina Research

Erie, Pennsylvania, 16507-1429

United States

Palmetto Retina Center, LLC

West Columbia, South Carolina, 29169

United States

Palmetto Retina Center

West Columbia, South Carolina, 29169

United States

Tennessee Retina PC

Nashville, Tennessee, 37203

United States

Austin Retina Associates

Austin, Texas, 78705-1169

United States

Retina Consultants of Texas

The Woodlands, Texas, 77384-4167

United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, 84107

United States

Piedmont Eye Center

Lynchburg, Virginia, 24502

United States

Wagner Kapoor Institute

Norfolk, Virginia, 23502

United States

Retina Institute of Virginia

Richmond, Virginia, 23235

United States

Spokane Eye Clinical Research

Spokane, Washington, 99204

United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

Clinical Trials, STUDY_DIRECTOR, Genetech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2021-12-14

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Neovascular Age-related Macular Degeneration