Observational study on the use of Avacincaptad Pegol in patients with geographic atrophy
A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Astellas Pharma Inc · NCT06779773
This study looks at how well Avacincaptad pegol works and its safety for people with geographic atrophy from age-related macular degeneration by reviewing their medical records and collecting their feedback.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Astellas Pharma Inc (industry) |
| Locations | 65 sites (Phoenix, Arizona and 64 other locations) |
| Trial ID | NCT06779773 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals with geographic atrophy due to age-related macular degeneration (AMD). It aims to gather data on the treatment patterns and safety of Avacincaptad pegol, an approved therapy for this condition, by reviewing medical records of patients receiving this treatment in routine clinical practice. Participants will have geographic atrophy in one or both eyes and will be monitored for any medical issues related to the treatment. The study will also collect patient-reported outcomes to assess functional impacts.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with geographic atrophy secondary to AMD who are willing to receive treatment with Avacincaptad pegol.
Not a fit: Patients with contraindications to Avacincaptad pegol or those currently participating in other investigational programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Avacincaptad pegol for patients with geographic atrophy.
How similar studies have performed: While this study is observational, similar studies evaluating treatment patterns for geographic atrophy have shown promising results, indicating the potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes * Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment * Patient willingness to complete the patient reported outcome (PRO). Exclusion Criteria: * Patients who have any contraindication or are not eligible for treatment with ACP, including the following: * Active ocular or peri-ocular infection in either eye * Active, suspected intraocular inflammation in either eye at enrollment/baseline visit * Hypersensitive to ACP or to any ingredient in the formulation * Patients currently participating in an investigational program with interventions outside of routine clinical practice. * Patients who have received ACP in the study eye. Note: Patients who have received or are receiving ACP in the fellow eye are eligible to be included in the study. * Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.
Where this trial is running
Phoenix, Arizona and 64 other locations
- Phoenix Retina Clinical Trials, LLC — Phoenix, Arizona, United States (RECRUITING)
- Retinal Consultants of AZ — Phoenix, Arizona, United States (RECRUITING)
- Retina Macula Institute of Arizona — Scottsdale, Arizona, United States (RECRUITING)
- The Retina Partners — Encino, California, United States (RECRUITING)
- Harvard Eye Associates — Laguna Hills, California, United States (RECRUITING)
- University of California Irvine Medical Center — Orange, California, United States (RECRUITING)
- Retina Consultants of Southern CA — Redlands, California, United States (RECRUITING)
- Retinal Consultants Medical Group Inc — Sacramento, California, United States (RECRUITING)
- Retina Macula Institute — Torrance, California, United States (RECRUITING)
- Rocky Mountain Lions Eye Institute — Aurora, Colorado, United States (RECRUITING)
- Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States (RECRUITING)
- Colorado Retina Associates, PLLC — Lakewood, Colorado, United States (RECRUITING)
- Coastal Eye Surgeons — Greenwich, Connecticut, United States (RECRUITING)
- Florida Eye Clinic — Altamonte Springs, Florida, United States (WITHDRAWN)
- Advanced Retina Institute — Bonita Springs, Florida, United States (RECRUITING)
- University of Miami — Coral Gables, Florida, United States (RECRUITING)
- Retina Care Specialists — Palm Beach Gardens, Florida, United States (RECRUITING)
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida — Tampa, Florida, United States (RECRUITING)
- Retina Specialists of Tampa — Wesley Chapel, Florida, United States (RECRUITING)
- Southeast Retina Center, P.C. — Augusta, Georgia, United States (RECRUITING)
- University Retina and Macula Associates, P.C. — Oak Forest, Illinois, United States (RECRUITING)
- Illinois Retina Associates — Oak Park, Illinois, United States (RECRUITING)
- Illinois Eye Center — Peoria, Illinois, United States (RECRUITING)
- Wolfe Eye Clinic — West Des Moines, Iowa, United States (RECRUITING)
- Cumberland Valley Retina Consultants,P.C. — Hagerstown, Maryland, United States (RECRUITING)
- Retina Specialists — Towson, Maryland, United States (WITHDRAWN)
- Retina Associates of Michigan — Grand Blanc, Michigan, United States (RECRUITING)
- Retina Consultants of Minnesota PLLC — Saint Louis Park, Minnesota, United States (RECRUITING)
- Mississippi Retina Associates — Madison, Mississippi, United States (RECRUITING)
- Brown Family Retina PLLC — Olive Branch, Mississippi, United States (RECRUITING)
- Deep Blue Retina Clinical Research — Southaven, Mississippi, United States (RECRUITING)
- Sierra Eye Associates — Reno, Nevada, United States (RECRUITING)
- Eye Associates of North Jersey PA — Dover, New Jersey, United States (RECRUITING)
- NJ Retina — Edison, New Jersey, United States (RECRUITING)
- NJ Retina — Lakewood, New Jersey, United States (RECRUITING)
- Monmouth Retina Consultants — Little Silver, New Jersey, United States (WITHDRAWN)
- NJ Retina — Toms River, New Jersey, United States (RECRUITING)
- SightMD — Brentwood, New York, United States (RECRUITING)
- Retina-Vitreous Surgeons of Central NY — Liverpool, New York, United States (RECRUITING)
- NY Retina Ophthalmology PLLC — Massapequa, New York, United States (ACTIVE_NOT_RECRUITING)
- Retina Associates of New York — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Long Island Vitreoretinal Consultants — Scarsdale, New York, United States (RECRUITING)
- Vitreoretinal Consultants — Shirley, New York, United States (RECRUITING)
- North Carolina Retina Associates — Cary, North Carolina, United States (WITHDRAWN)
- North Carolina Retina Associates — Wake Forest, North Carolina, United States (RECRUITING)
- The Ohio State University — Columbus, Ohio, United States (RECRUITING)
- CEI Physicians PSC, LLC dba — Dayton, Ohio, United States (RECRUITING)
- Verum Research, LLC — Eugene, Oregon, United States (RECRUITING)
- Erie Retina Research — Erie, Pennsylvania, United States (RECRUITING)
- Southeastern Retina Associates, P.C. — Knoxville, Tennessee, United States (RECRUITING)
+15 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: Astellas.registration@astellas.com
- Phone: 800-555-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Geographic Atrophy, Macular Degeneration, Avacincaptad Pegol, IZERVAY™, Treatment patterns, Safety, Functional Outcomes