Status:
COMPLETED
Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Lead Sponsor:
Alcon Research
Conditions:
Neovascular Age-Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injec...
Detailed Description
Subjects were randomized to brolucizumab 3 mg, brolucizumab 6 mg,and aflibercept 2 mg in a 1:1:1 ratio. Subjects in all treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), foll...
Eligibility Criteria
Inclusion
- Key
- Provide written informed consent
- Active choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) that affected the central subfield in the study eye at Screening;
- Total area of CNV comprising \>50% of the total lesion area in the study eye at Screening;
- Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
- Best Corrected Visual Acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
- Key
Exclusion
- Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
- Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at Screening;
- Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening;
- Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
- Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
- Pregnant or nursing women; women of child-bearing potential;
- Stroke or myocardial infarction in the 90-day period prior to Baseline.
Key Trial Info
Start Date :
December 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2018
Estimated Enrollment :
1775 Patients enrolled
Trial Details
Trial ID
NCT02307682
Start Date
December 8 2014
End Date
March 28 2018
Last Update
January 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134