The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy

Prospective study of neovascular AMD subjects with type 1, 2, or 3 neovascularization that
have not been treated with prior anti-VEGF therapy. Subjects will be scheduled for
intravitreal aflibercept injection (IAI) at baseline, week 4, week 8, week 16, week 24, week
36, and week 48. Additional injections can be administered during the remaining visits on an
as needed basis per PI discretion based on the presence of any intraretinal or subretinal
fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters,
or evidence of either increased area, density, or activity of the brush border of the
neovascularization on OCT angiography. There will be a minimum of 21 days between subsequent
injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum
of 13 injections throughout the study period. No injection will be given on the exit visit,
week 52. OCT angiography and spectral domain OCT imaging will be performed at baseline and
every 4 weeks thereafter

The above procedures are standard of care for neovascular AMD subjects.

As part of this study, these subjects will also undergo imaging of both eyes with OCTA at
each visit. This is not standard of Care and is research.

The only procedure that is being performed for research is the OCT-A. The injections and all
other procedure are SOC based on physician discretion and clinical need. The investigators
will not be modifying the dosage amounts or frequency.

A subgroup of willing subjects will undergo OCT angiography every 2 weeks for the first 12
weeks.

Indocyanine green angiography will be performed at baseline for all subjects to establish
baseline subject population characteristics. Fluorescein angiography will be performed at
baseline, week 12, and week 52 for efficacy monitoring. Detailed OCT angiography analysis
will be performed to identify anatomical and morphological biomarkers of growth progression
and disease activity. In addition to qualitative structural and morphological analysis,
detailed quantitative OCT angiography analysis of the neovascular lesion using automated or
manual capillary density maps and area calculation will be performed at each visit to
determine the detailed microvascular response of neovascular complexes to IAI therapy.

Inclusion Criteria:

1. Subject is older than 50 years of age.

2. Subject is willing to participate in the study and able to follow the study criteria
and protocol.

3. The study eye is treatment naive regarding treatment of neovascular AMD.

4. Subject is willing and able to comply with clinic visits and study-related procedures.

5. Subject is able to provide signed informed consent.

6. Subject is able to understand and complete study-related questionnaires.

7. The subject is not currently involved with any other clinical study.

8. Best Corrected Visual Acuity (BCVA) with ETDRS Snellen equivalent of 20/400 or better
and 20/32 or worse.

9. Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and
fundus photography (FP).

10. Intraocular pressure (IOP) of 25mmHg or less in the study eye, with or without use of
ocular hypotensive agents.

11. Prior focal corticosteroid treatment is allowed, as long as the study eye is not
involved. However prior (within 90 days of Day 0) or current systemic corticosteroid
therapy (oral or intravenous corticosteroid treatment) is not permitted.

Exclusion Criteria:

1. Any prior treatment of neovascular AMD in the eye proposed for enrollment including
previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy
(PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV,
thermal laser treatment, and any other prior intravitreal treatment for neovascular
AMD (except minerals and vitamins).

2. Known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG),
shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution
(e.g. Betadine Solution).

3. Prior or current systemic anti-VEGF therapy.

4. Pregnant or breast-feeding women.

5. Sexually active men* or women of childbearing potential** who are unwilling to
practice adequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
[IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or
jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

6. Contraindication to pupillary dilation in study eye.

7. Any condition (including inability to read visual acuity charts, or language barrier)
that may preclude subjects ability to comply with the study protocol and requirements.

8. Presence of any advanced systemic condition or end-stage disease, such as advanced
Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from
completing study.

9. Previous therapeutic radiation in the region of the study eye.

10. Prior retinal pigment epithelial (RPE) tear in study eye.

11. Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days.

12. Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.

13. Prior vitrectomy in the study eye.

14. Presence of any causes of CNV and PED other than due to AMD or presence of ocular
disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis
syndrome, android streaks, pathologic myopia