A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
NCT ID: NCT01940900
Last Updated: 2024-10-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
627 participants
INTERVENTIONAL
2013-08-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
NCT01944839
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis
NCT00804934
A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
NCT02387957
Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD
NCT00574093
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
NCT00680498
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
E10030
ranibizumab
Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
ranibizumab
E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E10030
ranibizumab
E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ophthotech Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tucson, Arizona, United States
Tucson, Arizona, United States
Fresno, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Mountain View, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Aurora, Colorado, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Largo, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Harvey, Illinois, United States
West Des Moines, Iowa, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Peabody, Massachusetts, United States
Worcester, Massachusetts, United States
Minneapolis, Minnesota, United States
Lawrenceville, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Greenville, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Bellevue, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
East Melbourne, , Australia
Malvern, , Australia
Nedlands, , Australia
Parramatta, , Australia
Sydney, , Australia
Westmead, , Australia
Bogotá, , Colombia
Cali, , Colombia
Medellín, , Colombia
Aalborg, , Denmark
Aarhus C, , Denmark
Glostrup Municipality, , Denmark
Odense, , Denmark
Roskilde, , Denmark
Créteil, , France
Lyon, , France
Lyon, , France
Marseille, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Tours, , France
Aachen, , Germany
Bonn, , Germany
Cologne, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Karlsruhe, , Germany
Kiel, , Germany
Leipzig, , Germany
Lübeck, , Germany
Mainz, , Germany
München, , Germany
München, , Germany
Münster, , Germany
Münster, , Germany
Tübingen, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Magyarszék, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Barcelona, , Spain
Bilbao, , Spain
Las Palmas, , Spain
Navarro, , Spain
Sant Cugat del Vallès, , Spain
Valencia, , Spain
Ankara, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OPH1003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.