A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
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|ClinicalTrials.gov Identifier: NCT01940900|
Recruitment Status : Terminated
First Posted : September 12, 2013
Results First Posted : August 15, 2018
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: E10030 Drug: ranibizumab Drug: E10030 sham intravitreal injection||Phase 3|
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 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 (Clinical Trial)|
|Actual Enrollment :||627 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Other Name: Fovista®
Other Name: Lucentis®
Active Comparator: Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Other Name: Lucentis®
Drug: E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Other Name: Sham
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940900