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 (NCT04108156)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barnet Dulaney Perkins Eye Center — Mesa, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (88 Sites)
Showing the first 25 of 88 sites.
- Barnet Dulaney Perkins Eye Center — Mesa, Arizona
- Retinal Consultants of Arizona;Opthalmology — Phoenix, Arizona
- Arizona Retina and Vitreous Consultants — Phoenix, Arizona
- Associated Retina Consultants — Phoenix, Arizona
- California Retina Consultants — Bakersfield, California
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- The Retina Partners — Encino, California
- Retina Consultants of Orange County;Clinical Research — Fullerton, California
- Jules Stein Eye Institute/ UCLA — Los Angeles, California
- Northern California Retina-Vitreous Associates — Mountain View, California
- East Bay Retina Consultants — Oakland, California
- Doheny Eye Institute — Pasadena, California
- California Eye Specialists Medical Group — Pasadena, California
- Retina Consultants Medical Group — Sacramento, California
- Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California
- Orange County Retina Medical Group — Santa Ana, California
- California Retina Consultants;Research Department — Santa Barbara, California
- Eye Center of Northern Colorado — Fort Collins, Colorado
- Colorado Clinical Research — Lakewood, Colorado
- Retina Group of New England — Waterford, Connecticut
- Retina Group of Florida — Fort Lauderdale, Florida
- National Ophthalmic Research Institute — Fort Myers, Florida
- Retina Specialty Institute — Pensacola, Florida
- Fort Lauderdale Eye Institute — Plantation, Florida
- Retina Vitreous Associates of Florida — St. Petersburg, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Macular Edema
- Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT) — Beverly Hills, California
- 4D-150 in Patients With Diabetic Macular Edema — Hagerstown, Maryland
- Mean Visual Acuity Changes Following Five Injections of Aflibercept — Hamilton, Ontario
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME) — Mesa, Arizona
- A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema — Phoenix, Arizona
Explore by condition: All Diabetic Macular Edema clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.