Wet Age-related Macular Degeneration Clinical Trial
Official title:
A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
| Verified date | February 2022 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | October 18, 2018 |
| Est. primary completion date | October 18, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: - Active subfoveal NVAMD Exclusion Criteria: - History or evidence of severe cardiac disease - Any major surgical procedure within one month of trial entry - Subjects with a clinically significant laboratory value - Any treatment with an investigational agent in the past 60 days for any condition - Women who are pregnant or nursing - Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation - Any prior treatment for AMD other than oral supplements of vitamins and minerals |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Budapest Retina Associates | Budapest | |
| Hungary | Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont | Budapest | |
| Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika | Szeged | |
| Latvia | Dr. Solomatin's eye rehabilitation and vision correction centre | Riga | |
| Latvia | Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology | Riga | |
| United States | Retina Research Institute of Texas | Abilene | Texas |
| United States | Florida Eye Clinic | Altamonte Springs | Florida |
| United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
| United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
| United States | Retina Consultants of Orange County | Fullerton | California |
| United States | Colorado Retina Associates | Golden | Colorado |
| United States | Retina Consultants of Nevada | Henderson | Nevada |
| United States | Charleston Neuroscience Institute | Ladson | South Carolina |
| United States | Florida Eye Associates | Melbourne | Florida |
| United States | VitreoRetinal Surgery | Minneapolis | Minnesota |
| United States | Illinois Eye Center | Peoria | Illinois |
| United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
| United States | Retinal Research Institute | Phoenix | Arizona |
| United States | Retina Northwest PC | Portland | Oregon |
| United States | Retina Consultants of Southern California | Redlands | California |
| United States | Sierra Eye Associates | Reno | Nevada |
| United States | Retinal Consultants Medical Group | Sacramento | California |
| United States | Orange County Retina Medical Group | Santa Ana | California |
| United States | Retina Vitreous Surgeons of CNY, PC | Syracuse | New York |
| United States | Retina Associates SW, PC | Tucson | Arizona |
| United States | Retina Centers PC | Tucson | Arizona |
| United States | Vitreo Retinal Consultants & Surgeons | Wichita | Kansas |
| United States | Strategic Clinical Research Group | Willow Park | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Ophthotech Corporation |
United States, Hungary, Latvia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change From Baseline - ECG | Number of patients with a change on their Month 6 ECG when compared to their baseline ECG | 6 months | |
| Other | Mean Change From Baseline - Study Eye ETDRS Visual Acuity | Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning. | 6 months | |
| Other | Mean Change From Baseline - Vital Signs | Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase. | 6 months | |
| Primary | Systemic Adverse Events | Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage) | 6 months | |
| Primary | Ophthalmic Adverse Events | Number of participants with ophthalmic Adverse Events (with calculated percentage) | 6 months |
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