Status:
COMPLETED
Efficacy and Safety Study of ESBA1008 Versus EYLEA®
Lead Sponsor:
Alcon Research
Conditions:
Exudative Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.
Detailed Description
This study consisted of 16 visits (Screening, Baseline \[Day 0\], and 14 post-baseline assessment visits) that occurred at 4-week intervals through Week 56. Enrolled subjects were randomized 1:1 to re...
Eligibility Criteria
Inclusion
- Give written informed consent; be able to make the required study visits and follow instructions.
- Diagnosis of wet age-related macular degeneration, as specified in protocol.
- Best-corrected visual acuity (BCVA) as specified in protocol
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Either eye: Any active ocular or periocular infection or active intraocular inflammation.
- Study eye: Any approved or investigational treatment for exudative AMD other than vitamin supplements.
- Study eye: Any current or history of macular or retinal disease other than exudative AMD.
- Study eye: Any concurrent intraocular condition that, in the opinion of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat vision loss, or that limits the potential to gain visual acuity with the investigational product.
- Study eye: Uncontrolled glaucoma.
- Study eye: Any ocular disease that, in the opinion of the Investigator, could compromise the visual acuity.
- Study eye: History of eye surgery, as specified in protocol.
- Study eye: Use of corticosteroids, as specified in protocol.
- Any medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or safe administration of investigational product.
- Any screening laboratory result that, in the opinion of the Investigator, would make the patient unsuitable for study participation.
- History of hypersensitivity to any component used in the study, as assessed by the Investigator.
- Women of childbearing potential: Lactating, pregnant, plan to become pregnant, or not using adequate birth control, as specified in protocol.
- Participation in an investigational drug or device study within time period specified in protocol.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01796964
Start Date
March 1 2013
End Date
August 1 2014
Last Update
February 9 2016
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