ESBA1008 Microvolume Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/7/2015
Start Date:June 2013
End Date:January 2015
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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A Prospective, Two-Staged, Single-Masked Study to Evaluate the Effect of ESBA1008 Applied by Microvolume Injection or Infusion in Subjects With Exudative Age-Related Macular Degeneration

The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a
microvolume injection or infusion on retinal function and morphology in subjects with
exudative age-related macular degeneration (AMD).

This 4-cohort study will be conducted in 2 stages. In Stage 1, subjects will be randomized
to receive 2 ESBA1008 injections (Cohort 1), 1 ESBA1008 infusion and 1 injection (Cohort 2),
or 2 LUCENTIS injections (Cohort 1 and 2). Stage 2 will be conducted similarly with a
different dosing level for ESBA1008 (Cohort 3 and 4). After the Day 28 visit (all cohorts),
subjects will return for follow up visits at Day 42 and Day 56.

Inclusion Criteria:

- Sign informed consent document;

- Able to make the required study visits and follow instructions;

- Age-related macular degeneration in the study eye;

- Visual acuity within protocol-specified range;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Both eyes: Any active infection or inflammation;

- Study eye: Any treatment for exudative age-related macular degeneration (AMD) other
than vitamin supplements;

- Study eye: Any current or history of macular or retinal disease;

- Study eye: Any concurrent intraocular condition such as cataract or diabetic
retinopathy that, in the opinion of the Investigator, could either require medical or
surgical intervention during the course of the study to prevent or treat visual loss;

- Study eye: Other ocular conditions or diseases that, in the opinion of the
Investigator, could compromise visual acuity;

- Study Eye: Uncontrolled glaucoma;

- History of a medical condition that, in the opinion of the Investigator, would
preclude scheduled study visits, completion of the study, or a safe administration of
investigational product;

- Women of childbearing potential who are lactating, pregnant, planning to become
pregnant, or not using adequate birth control methods for the duration of the study;

- Intraocular surgery within 3 months of baseline;

- Study eye: Any history or current evidence of retinal angiomatous proliferation (RAP)
lesions based on clinical exam;

- Other protocol-defined exclusion criteria may apply.
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Fort Worth, Texas 76134
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