A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration

This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable
solution administered in 9, and up to 12, subjects with late stage exudative age-related
macular degeneration.

Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye.
Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120
injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the
Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.

The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose
DE-120) and Cohort 3 (High Dose DE-120).

Main Inclusion Criteria:

- Understand and provide signed written informed consent

- Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative
age-related macular degeneration in the study eye

- At least one lesion in the study eye that meets minimal pathology criteria

- Visual acuity of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study
eye, excluding No Light Perception

- Reasonably clear media and some fixation in the study eye

Main Exclusion Criteria:

Ocular

- Visual acuity of No Light Perception

- Aphakic or has an anterior chamber intraocular lens in the study eye.

- Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the
study eye for the treatment of AMD within a specified timeframe prior to Visit 1

- Uncontrolled glaucoma, chronic hypotony or vitrectomy in the study eye

- Evidence of any other ocular disease other than late stage exudative age related
macular degeneration in the study eye that may confound the outcome of the study .

- Proscribed ocular surgery in the study eye either prior to or during the course of
the trial

- Presence or history of certain ocular or periocular pathology or conditions that
could limit ability to perform required study assessments in either eye and/or
confound study results

Non-Ocular

- Systemic treatment with anti-VEGF agents (e.g., bevacizumab) is prohibited at any
time during the study

- Allergy or hypersensitivity to study drug product, fluorescein dye, or other study
related procedures/medications.

- Current or history of certain systemic conditions, abnormalities or therapies that
would render a subject a poor candidate for a clinical trial

- Participation in other investigational drug or device clinical trials within 30 days
prior to Screening or planning to participate in other investigational drug or device
clinical trials for the duration of the study

- Females who are pregnant or lactating and females of child-bearing potential who are
not using adequate contraceptive precautions and men who do not agree to practice an
acceptable method of contraception throughout the course of the study

- Unable to comply with study procedures or follow-up visits