Actively Recruiting
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)
Led by Genentech, Inc. · Updated on 2026-05-12
188
Participants Needed
50
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating corneal endothelial cells in people with neovascular age-related macular degeneration (nAMD) who are treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV study is open-label and multicenter, aiming to assess changes in corneal endothelial cell density and other eye health measures in participants receiving this treatment. Participants will have the PDS implant surgically placed in the study eye at the beginning of the study. The implant is filled with a ranibizumab solution before insertion and then refilled every 24 weeks. Supplemental ranibizumab injections may also be given if needed. The study monitors the participants during the treatment period, which lasts up to approximately one year. During the study, participants will undergo exams including specular microscopy to measure corneal endothelial cell density, visual acuity tests, and other eye health assessments at baseline, 24 weeks, and 48 weeks. Researchers will track any serious or special ocular adverse events, device effects, and other safety outcomes. Participants are followed closely to understand the effects of the PDS implant and treatment on eye structures over time.
CONDITIONS
Brief Title
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with neovascular age-related macular degeneration (nAMD) before screening
- Less than 10% difference in corneal endothelial cell density between eyes at screening
- Availability of historical visual acuity and OCT imaging data; fluorescein angiography or fundus photography may also be used
- Availability of at least 2 years of anti-VEGF injection history or from diagnosis if less than 2 years
- Response to at least two prior anti-VEGF intravitreal injections with decreased disease activity and stable or improved vision
- Best-corrected visual acuity of approximately 20/200 or better in the study eye
- All nAMD lesion subtypes allowed; lesions must involve the macula at diagnosis
- Clear ocular media and good pupil dilation for clinical exams and imaging
You will not qualify if you...
- Prior external-beam radiation or transpupillary thermotherapy to study eye
- Previous verteporfin injection or corticosteroid intravitreal injection within 2 years
- Previous laser treatments for AMD except verteporfin injection
- History of corneal transplant or conjunctival surgery in superotemporal quadrant
- History of intraocular inflammation after anti-VEGF injection
- Previous PDS implantation in either eye
- Intraocular surgery within 6 months prior to enrollment
- Prior vitrectomy, submacular surgery, or other AMD surgeries
- History of glaucoma surgery or use of intraocular devices (excluding lenses)
- Participation in trials with unapproved intravitreal agents
- Recent intraocular laser therapies or contact lens use within 2 months
- Prior ocular trauma affecting corneal or retinal health
- Corneal endothelial cell density below 1500 cells/mm2 or certain corneal dystrophies
- Various active or history of ocular surface diseases and infections
- Uncontrolled ocular hypertension or glaucoma
- Severe eyelid or facial nerve conditions affecting eye protection
- Certain systemic conditions including uncontrolled blood pressure, recent stroke or heart attack, autoimmune diseases, active infections, cancer within 12 months except specific types
- Use of systemic anti-VEGF agents or chronic corticosteroids
- Pregnancy, breastfeeding, or intention to become pregnant; women of childbearing potential must have negative pregnancy tests before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants undergo surgery to have the Port Delivery System (PDS) implant with ranibizumab surgically inserted in the study eye. After the initial fill, participants receive implant refill-exchanges approximately every 24 weeks.
Visits at Day 1 for implantation and approximately every 24 weeks for implant refill-exchanges
Duration - Up to 52 weeks
Participants are monitored for ocular adverse events and safety outcomes after treatment, including assessments up to approximately Week 52.
Regular follow-up visits through Week 52
Trial Site Locations
Total: 50 locations
1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206-2747
Actively Recruiting
2
California Retina Consultants
Bakersfield, California, United States, 93309
Completed
3
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
Actively Recruiting
4
California Eye Specialists Medical group Inc.
Pasadena, California, United States, 91107-3747
Completed
5
Retinal Consultants Med Group
Sacramento, California, United States, 95841-2013
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94158-2510
Actively Recruiting
7
Orange County Retina Med Group
Santa Ana, California, United States, 92705-6504
Actively Recruiting
8
Macula Retina Vitreous Research Institute
Torrance, California, United States, 90503-3270
Actively Recruiting
9
Southwest Retina Consultants
Durango, Colorado, United States, 81303
Completed
10
Advanced Vision Research Institute
Longmont, Colorado, United States, 80503-6499
Actively Recruiting
11
Retina Group of New England
Waterford, Connecticut, United States, 06385-1215
Withdrawn
12
Retina Specialty Institute
Pensacola, Florida, United States, 32503-2030
Actively Recruiting
13
Ft Lauderdale Eye Institute
Plantation, Florida, United States, 33324-3118
Withdrawn
14
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711-1141
Actively Recruiting
15
Southeast Retina Center
Augusta, Georgia, United States, 30909-6440
Actively Recruiting
16
University Retina and Macula Associates, PC
Lemont, Illinois, United States, 60439-7421
Actively Recruiting
17
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
Withdrawn
18
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509-1827
Withdrawn
19
Maine Eye Center
Portland, Maine, United States, 04101
Actively Recruiting
20
The Retina Care Center
Baltimore, Maryland, United States, 21209-2219
Actively Recruiting
21
Wilmer Eye Institute Johns Hopkins University
Baltimore, Maryland, United States, 21287-0005
Actively Recruiting
22
Retina Group of Washington
Chevy Chase, Maryland, United States, 20815-6956
Withdrawn
23
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States, 21740
Completed
24
Associated Retinal Consultants PC
Royal Oak, Michigan, United States, 48073
Actively Recruiting
25
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States, 55435-3004
Actively Recruiting
26
Midwest Vision Research Foundation
Chesterfield, Missouri, United States, 63017-5065
Completed
27
Sierra Eye Associates
Reno, Nevada, United States, 89502-1605
Actively Recruiting
28
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
29
Seeta Eye Centers
Poughkeepsie, New York, United States, 12603-2416
Actively Recruiting
30
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States, 28803-2493
Withdrawn
31
Duke Eye Center
Durham, North Carolina, United States, 27705-4699
Actively Recruiting
32
Fargo Retina Consultants
Fargo, North Dakota, United States, 58047
Actively Recruiting
33
Cincinnati Eye Institute
Blue Ash, Ohio, United States, 45242-5537
Actively Recruiting
34
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
35
Tulsa Retina Consultants
Tulsa, Oklahoma, United States, 74114
Withdrawn
36
Erie Retina Research
Erie, Pennsylvania, United States, 16505
Actively Recruiting
37
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107-5109
Withdrawn
38
Palmetto Retina Center
Florence, South Carolina, United States, 29501
Withdrawn
39
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States, 29169-2429
Withdrawn
40
Charles Retina Institute
Germantown, Tennessee, United States, 38138-2405
Actively Recruiting
41
Tennessee Retina PC
Nashville, Tennessee, United States, 37203-1596
Actively Recruiting
42
Panhandle Eye Group LLP Southwest Retina Specialists
Amarillo, Texas, United States, 79106-1835
Completed
43
Austin Retina Associates
Austin, Texas, United States, 78705-1169
Withdrawn
44
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
45
Retina Consultants of Texas
Schertz, Texas, United States, 78154
Actively Recruiting
46
Retina Associates of Utah, PLLC
Salt Lake City, Utah, United States, 84107-6767
Actively Recruiting
47
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502-4271
Actively Recruiting
48
Wagner Kapoor Institute
Norfolk, Virginia, United States, 23502-3933
Actively Recruiting
49
Retina Institute of Virginia
Richmond, Virginia, United States, 23235-1962
Withdrawn
50
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Actively Recruiting
Research Team
R
Reference Study ID Number: ML43000 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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