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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362190
Other study ID # OPH2007
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 11, 2017
Est. completion date October 18, 2018

Study information

Verified date February 2022
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zimura
Zimura in combination with Lucentis
Lucentis
Zimura in combination with Lucentis

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ophthotech Corporation

Countries where clinical trial is conducted

United States,  Hungary,  Latvia, 

Outcome

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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