Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal APL-2 for Patients With Wet AMD

Inclusion Criteria:

1. Male or Female

2. Age ≥ 50 years

3. The presence of an active choroidal neovascular lesion secondary to AMD

4. On treatment with anti-VEGF therapy (Lucentis®, Eylea® or Avastin®)

5. Must have received at least 3 anti-VEGF treatments over the 26-week period prior to
screening (Screening Visit)

6. Evidence that the macular fluid has responded to anti-VEGF in the past based on OCT
in the opinion of PI

7. At screening, evidence of subretinal fluid and retinal cystic changes

8. Must have received anti-VEGF treatment within 10 days prior to APL-2 treatment
(anti-VEGF can be administered on the same day of the screening visit after the
screening procedures have been completed)

9. OCTs of sufficient quality to allow for the assessment of the central macular fluid
can be obtained

10. Female subjects must be:

- Women of non-child-bearing potential (WONCBP), Or

- 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

11. 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

12. Willing and able to give informed consent

Exclusion Criteria:

1. Choroidal neovascularization associated with other ocular diseases such as pathologic
myopia, ocular histoplasmosis or posterior uveitis, etc

2. Decreased vision due to retinal disease not attributable to choroidal
neovascularization, such as nonexudative forms of AMD, geographic atrophy, inherited
retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the
outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic
parafoveal telangiectasis, or central serous retinopathy

3. Additional ocular diseases that have irreversibly compromised or, during follow-up,
could likely compromise the VA of the study eye including amblyopia, anterior
ischemic optic neuropathy, clinically significant diabetic macular edema, severe non
proliferative diabetic retinopathy, or proliferative diabetic retinopathy

4. Decreased vision due to significant media opacity such as corneal disease or
cataract, or opacity precluding photography of the retina

5. Cataract surgery within three months of enrollment

6. Presence of any hemorrhage

7. History of treatment for CNV:

1. Previous PDT treatment within 30 days prior to enrollment in the study

2. Previous extrafoveal or juxtafoveal thermal laser photocoagulation within 30
days prior to enrollment in the study

8. Intraocular surgery (including lens replacement surgery) within 3 months prior to
randomization

9. Medical problems that make consistent follow-up over the treatment period unlikely
(e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk
because of other systemic diseases or active uncontrolled infections

10. Hypersensitivity to fluorescein