Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy

This is an open-label study, of intravitreally administered Ranibizumab in eyes with
Age-related Macular Degeneration (AMD), specifically looking at the correlation between the
presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of
Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be
enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment
(PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a
pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject
accrual into the trial is expected to be completed within 6 months.

All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for
four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits
monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed
basis, based on predefined criteria. Eyes will be evaluated with a full ocular examination,
visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos,
B-scan Ultrasound and subject adverse event monitoring.

Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study

- Subjects of either gender, Age greater than or equal to 50 years

- Best corrected visual acuity in the study eye between 20/25 and 20/320

- Subfoveal choroidal neovascularization, secondary to age related macular degeneration

- Total lesion size less than 4 disc diameters

- Any subretinal hemorrhage must comprise no more than 50% of total lesion size.

- Clear ocular media and adequate papillary dilation to permit good quality stereoscopic
fundus photography

- Ability to return for all study visits

Exclusion Criteria:

- Pregnancy (positive pregnancy test)or lactation

- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in conjunction
with spermicidal gel,an IUD,or contraceptive hormone implant or patch.

- Patients with any form of prior eye treatment for AMD including: Photodynamic Therapy,
anti-VEGF Therapy, Laser, Vitreoretinal surgery

- Had ocular surgery within the past 60 days in study eye

- Concurrent use of more than two therapies for glaucoma

- Uncontrolled glaucoma in the study eye(defined as intraocular pressure>30mm Hg despite
treatment with anti-glaucoma medication)

- Concurrent use of systemic anti-VEGF agents

- Has active infection in the study eye(s)

- Inability to obtain photographs to document CNV

- Has received investigational therapy within 60 days prior to study entry

- Patients with significantly compromised visual acuity in the study eye due to
concomitant ocular conditions.

- Has other conditions the investigator considers to be sound reasons for
exclusion(e.g., lack of motivation, history of poor compliance, concomitant illnesses,
personality disorder, mental condition, drug abuse, use of neuroleptics, physical or
social condition predicting difficulty in long-term follow-up).

- Has an allergy to sodium fluorescein dye

- Inability to comply with study or follow-up procedures