A Phase 3 Safety and Efficacy Study of Fovista™ (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Overview[ - collapse ][ - ]
| Purpose | 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). |
|---|---|
| Condition | Age-Related Macular Degeneration |
| Intervention | Drug: E10030 Drug: ranibizumab Drug: E10030 sham intravitreal injection |
| Phase | Phase 3 |
| Sponsor | Ophthotech Corporation |
| Responsible Party | Ophthotech Corporation |
| ClinicalTrials.gov Identifier | NCT01940900 |
| First Received | September 9, 2013 |
| Last Updated | March 18, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 9, 2013 |
|---|---|
| Last Updated Date | March 18, 2014 |
| Start Date | August 2013 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Mean Change in Visual Acuity from Baseline at the Month 12 Visit. [Time Frame: 12 Months] [Designated as safety issue: No]The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Phase 3 Safety and Efficacy Study of Fovista™ (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy |
|---|---|
| Official Title | 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. |
| Brief Summary | 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). |
| 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 |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Age-Related Macular Degeneration |
| Intervention | Drug: E10030 Other Names: Fovista™Drug: ranibizumab Other Names: Lucentis®Drug: E10030 sham intravitreal injection Pressure on the eye with a syringe with no needle Other Names: Sham |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 622 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | July 2016 |
| Eligibility Criteria | Inclusion Criteria: - Subjects of either gender aged ≥ 50 years - Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component 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 |
| Gender | Both |
| Ages | 50 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Walesca Ayala 212-845-8227 walesca.ayala@ophthotech.com |
| Location Countries | United States, Australia, Hungary |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01940900 |
|---|---|
| Other Study ID Numbers | OPH1003 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Ophthotech Corporation |
| Study Sponsor | Ophthotech Corporation |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| United States, Arizona | Tucson, Arizona, United States, 85710 Recruiting |
|---|---|
| United States, Arizona | Tucson, Arizona, United States, 85704 Recruiting |
| United States, California | Fresno, California, United States, 93720 Recruiting |
| United States, California | La Jolla, California, United States, 92093 Recruiting |
| United States, California | Loma Linda, California, United States, 92354 Recruiting |
| United States, California | Mountain View, California, United States, 94040 Recruiting |
| United States, California | Sacramento, California, United States, 95819 Recruiting |
| United States, California | Santa Ana, California, United States, 92705 Recruiting |
| United States, Colorado | Aurora, Colorado, United States, 80045 Recruiting |
| United States, Florida | Boynton Beach, Florida, United States, 33426 Recruiting |
| United States, Florida | Fort Myers, Florida, United States, 33912 Recruiting |
| United States, Florida | Ft. Lauderdale, Florida, United States, 33308 Recruiting |
| United States, Florida | Largo, Florida, United States, 33770 Recruiting |
| United States, Florida | Orlando, Florida, United States, 32806 Recruiting |
| United States, Georgia | Atlanta, Georgia, United States, 30322 Recruiting |
| United States, Georgia | Augusta, Georgia, United States, 30909 Recruiting |
| United States, Illinois | Harvey, Illinois, United States, 60426 Recruiting |
| United States, Iowa | West Des Moines, Iowa, United States, 50266 Recruiting |
| United States, Kansas | Shawnee Mission, Kansas, United States, 66204 Recruiting |
| United States, Kansas | Wichita, Kansas, United States, 67214 Recruiting |
| United States, Maryland | Baltimore, Maryland, United States, 21209 Recruiting |
| United States, Maryland | Hagerstown, Maryland, United States, 21740 Recruiting |
| United States, Massachusetts | Peabody, Massachusetts, United States, 01960 Recruiting |
| United States, Massachusetts | Worcester, Massachusetts, United States, 01605 Recruiting |
| United States, Minnesota | Minneapolis, Minnesota, United States, 55435 Recruiting |
| United States, New Jersey | Lawrenceville, New Jersey, United States, 08648 Recruiting |
| United States, New York | New York, New York, United States, 10022 Recruiting |
| United States, New York | Syracuse, New York, United States, 13224 Recruiting |
| United States, North Carolina | Ashville, North Carolina, United States, 28803 Recruiting |
| United States, North Carolina | Charlotte, North Carolina, United States, 28210 Recruiting |
| United States, North Carolina | Winston-Salem, North Carolina, United States, 27157 Recruiting |
| United States, Ohio | Cleveland, Ohio, United States, 44122 Recruiting |
| United States, Ohio | Cleveland, Ohio, United States, 44130 Recruiting |
| United States, Oklahoma | Oklahoma City, Oklahoma, United States, 73104 Recruiting |
| United States, South Carolina | Greenville, South Carolina, United States, 29605 Recruiting |
| United States, South Carolina | West Columbia, South Carolina, United States, 29169 Recruiting |
| United States, South Dakota | Rapid City, South Dakota, United States, 57701 Recruiting |
| United States, Tennessee | Nashville, Tennessee, United States, 37203 Recruiting |
| United States, Texas | Austin, Texas, United States, 78705 Recruiting |
| United States, Texas | Dallas, Texas, United States, 75231 Recruiting |
| United States, Texas | Houston, Texas, United States, 77030 Recruiting |
| United States, Texas | McAllen, Texas, United States, 78503 Recruiting |
| United States, Texas | San Antonio, Texas, United States, 78240 Recruiting |
| United States, Utah | Salt Lake City, Utah, United States, 84107 Recruiting |
| United States, Virginia | Richmond, Virginia, United States, 23226 Recruiting |
| United States, Virginia | Virginia Beach, Virginia, United States, 23454 Recruiting |
| United States, Washington | Bellevue, Washington, United States, 98004 Recruiting |
| Australia, New South Wales | Parramatta, New South Wales, Australia, 2150 Recruiting |
| Australia, Western Australia | Nedlands, Western Australia, Australia, 6009 Recruiting |
| Hungary, Central Hungary | Budapest, Central Hungary, Hungary, H-1083 Recruiting |
| Hungary, Central Hungary | Budapest, Central Hungary, Hungary, H-1145 Recruiting |
| Hungary, Central Hungary | Budapest, Central Hungary, Hungary, 1106 Recruiting |
| Hungary, Northern Great Plain | Debrecen, Northern Great Plain, Hungary, H-4012 Recruiting |
| Hungary, Southern Great Plain | Szeged, Southern Great Plain, Hungary, 6720 Recruiting |
| Hungary | Budapest, Hungary, 1133 Recruiting |
| Hungary | Pecs, Hungary, 7621 Recruiting |