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