FILLY APL-2

Principal Investigator: Paul Bernstein
Keywords: Age-related macular degeneration (AMD) , Geographic atrophy (GA) Department: Ophthalmology-Services
IRB Number: 00089899 Co Investigator:  
Specialty: Ophthalmology
Sub Specialties: Retinal Diseases
Recruitment Status: Active, not recruiting

Contact Information

Barbara Hart
barbara.hart@hsc.utah.edu
801-581-6459

Brief Summary

The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).

Inclusion Criteria

Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.
1. Male or Female.
2. Age ≥ 50 years.
3. Best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent).
4. Diagnosis of GA of the macula secondary to AMD, confirmed within 14 days prior to randomization by the central reading center (CRC) using Fundus Autofluorescence (FAF) images, as well as the following criteria:
a. Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively), determined by screening images of FAF.
b. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA).
c. GA can be completely visualized on the macula centered image.
d. GA must be able to be photographed in its entirety.
e. GA must be able to be measured separately from any areas of peripapillary atrophy as assessed by the CRC.
f. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary. 
5. Female subjects must be:
a. Women of non-child-bearing potential (WONCBP), or
b. Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study.
6. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
7. Willing and able to give informed consent.
 
Note: If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the study eye.

Exclusion Criteria

Unless specified otherwise, ocular specific exclusion criteria apply to the study eye only.
1. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.
2. Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
3. Any history or current evidence of exudative (“wet”) AMD including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the CRC.
4. Retinal disease other than AMD; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e. pavingstone degeneration).
5. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).
6. Any ophthalmologic condition that prevents adequate imaging of the retina judged by the site or CRC.
7. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
8. Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 0.
9. Any ophthalmic condition that may require surgery during the study period.
10. Any contraindication to IVT injection including current ocular or periocular infection.
11. History of uveitis or endophthalmitis.
12. History of IVT injection at any time.
13. 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. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
14. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
15. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
16. Hypersensitivity to fluorescein.