A Phase 3 Safety and Efficacy Study of Fovista™ (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). |
|---|---|
| Condition | Age-Related Macular Degeneration |
| Intervention | Drug: E10030 Drug: bevacizumab or aflibercept Drug: E10030 sham intravitreal injection |
| Phase | Phase 3 |
| Sponsor | Ophthotech Corporation |
| Responsible Party | Ophthotech Corporation |
| ClinicalTrials.gov Identifier | NCT01940887 |
| First Received | September 9, 2013 |
| Last Updated | November 19, 2013 |
| Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 9, 2013 |
|---|---|
| Last Updated Date | November 19, 2013 |
| Start Date | March 2014 |
| 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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 either Avastin® or Eylea® compared to Avastin® or Eylea® 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 + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye - Fovista™ sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye Subjects will be treated for a total of 24 months with active Fovista™ or sham in combination with either Avastin® or Eylea® 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: bevacizumab or aflibercept Patients are randomized to receive either bevacizumab or aflibercept Other Names:
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 | Not yet 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: Karen Lewis 212-845-8223 Karen.Lewis@ophthotech.com |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01940887 |
|---|---|
| Other Study ID Numbers | OPH1004 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Ophthotech Corporation |
| Study Sponsor | Ophthotech Corporation |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | November 2013 |