A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:June 2012
End Date:April 2014
Contact:Contact Alcon Call Center for Trial Locations
Phone:1-888-451-3937

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A Multicenter, Randomized, Double-Masked, Sham-Controlled, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)


The purpose of this study is to evaluate the safety and efficacy of 12 monthly IVT
injections of 0.400 mcg of AL-78898A, a C3 inhibitor, in slow down the rate of progression
from base line, of GA lesion size in patients diagnosed with Geographic Atrophy (GA)
associated with Age-Related Macular Degeneration (AMD).


Inclusion Criteria:

1. Patients of age 55 or older at Screening.

2. Ability to provide informed consent and comply with the protocol.

3. Diagnosis of geographic atrophy (GA) of the macula caused by age-related macular
degeneration, confirmed within 14 days prior to randomization by the central reading
center using fundus autofluorescence images, as well as the following criteria:

- Total GA area in study eye must be of size 1.25-20 mm2 (0.5 - 8 DA), determined
by screening images of fundus autofluorescence photographs.

- GA in the study eye can be completely visualized on the macula centered image
(Field 2 - Macula Image).

- GA must be able to be photographed in its entirety and not contiguous with any
areas of peripapillary atrophy. Images must include the modified 3- field images
as defined by the University of Wisconsin standards.

4. BCVA of 20 letters (20/400 Snellen equivalent) or better in the study eye at
screening.

5. BCVA of 20 letters (20/400 Snellen equivalent) or better in the non study eye at
screening without conditions other than AMD that, in the opinion of the investigator,
could cause a rapid loss of vision.

Exclusion Criteria:

1. Any history or current evidence of exudative ("wet") AMD in study eye including any
evidence of retinal pigment epithelium rips or evidence of neovascularization
anywhere in the retina based on fluorescein angiogram per Investigator judgment.

2. Retinal disease other than AMD in the study eye; however, benign conditions of the
vitreous or peripheral retina are not exclusionary (ie, pavingstone degeneration).

3. Any ophthalmologic condition in study eye that reduces the clarity of the media and
that, in the opinion of the Investigator interferes with ophthalmologic examination
(eg, advanced cataract or corneal abnormalities).

4. Any ophthalmologic condition in study eye that prevents adequate imaging of the
retina judged by the site or reading center.

5. A history or current medical diagnosis of glaucoma or ocular hypertension in study
eye

6. Any ophthalmic condition in study eye that may require surgery during the study
period.

7. Any contraindication to intravitreal injection including current ocular or periocular
infection in the study eye.

8. History of any disease or current use of medication expected to cause systemic or
ocular immunosuppression (including RESTASIS® use in the study eye).

9. History of uveitis or endophthalmitis in the study eye.

10. History of intraocular surgery (including cataract surgery) in the study eye within
90 days prior to dosing.

11. History of IVT or periocular injection in the study eye at anytime.

12. Participation in another interventional clinical study, or use of any experimental
treatment for AMD or any other investigational new drug within 6 weeks or 5
half-lives of the active (whichever is longer) prior to the start of study treatment.

13. History of any medical or psychiatric condition, or substance abuse, that in the
Investigator's opinion is likely to interfere with the patient's participation in the
study, or likely to cause serious adverse events during the study.

14. Women of child bearing potential UNLESS they are using a highly effective method of
birth control, postmenopausal, or have had well-documented surgical sterilization
procedures (see the Manual of Procedures).

15. Known or suspected allergy or hypersensitivity to fluorescein or other injectables.
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Fort Worth, Texas 76134
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