Efficacy and Safety Study of ESBA1008 Versus EYLEA®



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:7/16/2013
Start Date:March 2013
End Date:November 2013
Contact:Alcon Call Center
Phone:1-888-451-3937

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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


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.


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 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.
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