Overview

This trial is active, not recruiting.

Condition exudative age-related macular degeneration
Treatments esba1008 solution, aflibercept
Phase phase 2
Target VEGF
Sponsor Alcon Research
Start date March 2013
End date October 2013
Trial size 173 participants
Trial identifier NCT01796964, C-12-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
esba1008 solution
For intravitreal (IVT) injection
(Active Comparator)
Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
aflibercept EYLEA®
For intravitreal (IVT) injection

Primary Outcomes

Measure
Change from Baseline in Visual Acuity at Week 12
time frame: Baseline, Week 12

Secondary Outcomes

Measure
Change from Baseline in Visual Acuity at Week 16
time frame: Baseline, Week 16
Change from Baseline in Visual Acuity, Up to Week 56
time frame: Baseline, Up to Week 56
Change from Baseline in Central Subfield (CSF) Thickness by Visit
time frame: Up to Week 56

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title A Prospective, Randomized, Double-Masked, Multicenter, Two Arm Study Comparing the Efficacy and Safety of ESBA1008 Versus EYLEA® in Subjects With Exudative Age-Related Macular Degeneration
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Alcon Research.