A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

February 20, 2024 updated by: Ophthotech Corporation

A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomized in a 1:1 ratio to the following dose groups:

  • Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
  • Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Study Type

Interventional

Enrollment (Actual)

627

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
      • Buenos Aires, Argentina, B1629ODT
      • Buenos Aires, Argentina, C1120AAN
      • Buenos Aires, Argentina, C1122AAI
      • Cordoba, Argentina, 5000
      • Santa Fe, Argentina, 2000
  • Australia
      • East Melbourne, Australia, 3002
      • Malvern, Australia, 3144
      • Nedlands, Australia, 6009
      • Parramatta, Australia, 2150
      • Sydney, Australia, 2000
      • Westmead, Australia, 2145
  • Colombia
      • Bogota, Colombia, 110311
      • Cali, Colombia, 76001000
      • Medellin, Colombia
  • Denmark
      • Aalborg, Denmark, 9000
      • Aarhus C, Denmark, 8000
      • Glostrup, Denmark, 2600
      • Odense, Denmark, 5000
      • Roskilde, Denmark, 4000
  • France
      • Créteil, France, 94010
      • Lyon, France, 69317
      • Lyon, France, 69003
      • Marseille, France, 13008
      • Paris, France, 75015
      • Paris, France, 75019
      • Paris, France, 75006
      • Paris, France, 75745
      • Rouen, France, 76100
      • Strasbourg, France, 67091
      • Tours, France, 37000
  • Germany
      • Aachen, Germany, 52057
      • Bonn, Germany, 53127
      • Freiburg, Germany, 79106
      • Göttingen, Germany, 37075
      • Hamburg, Germany, 20246
      • Heidelberg, Germany, 69120
      • Karlsruhe, Germany, 76131
      • Kiel, Germany, 24105
      • Köln, Germany, 50924
      • Leipzig, Germany, D-04103
      • Luebeck, Germany, 23538
      • Mainz, Germany, 55131
      • Muenchen, Germany, 80336
      • Muenster, Germany, 48165
      • München, Germany, 81675
      • Münster, Germany, 48145
      • Tübingen, Germany, 72076
  • Hungary
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Budapest, Hungary, 1076
      • Budapest, Hungary, H-1145
      • Budapest, Hungary, H-1083
      • Debrecen, Hungary, H-4012
      • Magyarszék, Hungary, 8200
      • Pecs, Hungary, 7621
      • Szeged, Hungary, 6720
  • Israel
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Kfar-Saba, Israel, 4428164
      • Petah Tikva, Israel, 49100
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
  • Spain
      • Barcelona, Spain, 08022
      • Bilbao, Spain, 48006
      • Las Palmas, Spain, 35016
      • Navarro, Spain, 31008
      • Sant Cugat Del Vallès, Spain, 08195
      • Valencia, Spain, 46015
  • Turkey
      • Ankara, Turkey, 6100
      • Izmir, Turkey, 35100
      • Izmir, Turkey, 35340
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
      • Tucson, Arizona, United States, 85710
    • California
      • Fresno, California, United States, 93720
      • La Jolla, California, United States, 92093
      • Loma Linda, California, United States, 92354
      • Mountain View, California, United States, 94040
      • Sacramento, California, United States, 95819
      • Santa Ana, California, United States, 92705
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Golden, Colorado, United States, 80401
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Myers, Florida, United States, 33912
      • Largo, Florida, United States, 33770
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Harvey, Illinois, United States, 60426
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
      • Wichita, Kansas, United States, 67214
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
      • Worcester, Massachusetts, United States, 01605
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • New York
      • New York, New York, United States, 10022
      • Syracuse, New York, United States, 13224
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Charlotte, North Carolina, United States, 28210
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Cleveland, Ohio, United States, 44130
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • West Columbia, South Carolina, United States, 29169
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
      • San Antonio, Texas, United States, 78233
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23226
      • Virginia Beach, Virginia, United States, 23454
    • Washington
      • Bellevue, Washington, United States, 98004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria:

  • Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
  • Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
  • Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
  • Subjects with subfoveal scar or subfoveal atrophy are excluded
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Drug: E10030
Other Names:
  • Fovista®
Drug: ranibizumab
Other Names:
  • Lucentis®
Active Comparator: Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Drug: ranibizumab
Other Names:
  • Lucentis®
Drug: E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Visual Acuity From Baseline to 12 Months
Time Frame: 12 Months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthotech Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimated)

September 12, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data at this time

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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