ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

NCT ID: NCT03362190

Last Updated: 2025-06-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2018-10-18

Brief Summary

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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)

Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg

Group Type EXPERIMENTAL

Avacincaptad Pegol

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Lucentis

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Cohort 2

Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg

Group Type EXPERIMENTAL

Avacincaptad Pegol

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Lucentis

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Cohort 3

Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg

Group Type EXPERIMENTAL

Avacincaptad Pegol

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Lucentis

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Cohort 4

Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg

Group Type EXPERIMENTAL

Avacincaptad Pegol

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Lucentis

Intervention Type DRUG

Avacincaptad Pegol in combination with Lucentis

Interventions

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Avacincaptad Pegol

Avacincaptad Pegol in combination with Lucentis

Intervention Type DRUG

Lucentis

Avacincaptad Pegol in combination with Lucentis

Intervention Type DRUG

Other Intervention Names

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Zimura (previous name) IZERVAY ARC1905 ranibizumab

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthotech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retinal Research Institute

Phoenix, Arizona, United States

Site Status

Retina Centers PC

Tucson, Arizona, United States

Site Status

Retina Associates SW, PC

Tucson, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Retina Consultants of Orange County

Fullerton, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status

Orange County Retina Medical Group

Santa Ana, California, United States

Site Status

Colorado Retina Associates

Golden, Colorado, United States

Site Status

Florida Eye Clinic

Altamonte Springs, Florida, United States

Site Status

Florida Eye Associates

Melbourne, Florida, United States

Site Status

Illinois Eye Center

Peoria, Illinois, United States

Site Status

Vitreo Retinal Consultants & Surgeons

Wichita, Kansas, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

VitreoRetinal Surgery

Minneapolis, Minnesota, United States

Site Status

Retina Consultants of Nevada

Henderson, Nevada, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Retina Vitreous Surgeons of CNY, PC

Syracuse, New York, United States

Site Status

Retina Northwest PC

Portland, Oregon, United States

Site Status

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Site Status

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Site Status

Retina Research Institute of Texas

Abilene, Texas, United States

Site Status

Strategic Clinical Research Group

Willow Park, Texas, United States

Site Status

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

Budapest, , Hungary

Site Status

Budapest Retina Associates

Budapest, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika

Szeged, , Hungary

Site Status

Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology

Riga, , Latvia

Site Status

Dr. Solomatin's eye rehabilitation and vision correction centre

Riga, , Latvia

Site Status

Countries

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United States Hungary Latvia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.trialsummaries.com/Study/StudyDetails?id=26400&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website

https://www.clinicaltrials.astellas.com/study/OPH2007/

Link to results and other applicable study documents on the Astellas Clinical Trials website

Other Identifiers

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OPH2007

Identifier Type: -

Identifier Source: org_study_id

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