This trial has ended

Research Title: A Phase 3 Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

Sponsor: Ophthotech Corporation

Principal Investigator: Atul Sharma, M.D.

Description: Subjects will be randomized in a 1:1 ratio to the following dose groups:

Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye
Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye

Subjects will be treated for up to 24 months with active Fovista® or sham in combination with either Avastin® or Eylea® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Start Date: November 2015

Recruitment: Completed

Project Personnel: Leslie Marcus, CCRC

Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060

Clinical Trial Team

Active Trials

Novartis CRTH258C2302 Raven

Past Trials

What Our Patients Say

"I would first like to say, that it is a pleasure coming every month to get my eye injections solely based on the staff and my retina specialist! They are always so sweet, well educated, and very welcoming!"

- Hayley

"The staff is kind and very well informed. They walk you through exactly what is happening and give you all your options upfront (including financials). I would 100% recommend and I will be back for an annual checkup!"

- Pardis

"I have a great experience with Georgia Retina staff they make me feel right at home when I walk through the doors."

- Michael

"Dr. Stallman is an excellent physician. The staff in this office give excellent service extrodinar. They are all very kind, professional, and genuinely concerned about your care. Love these folks!"

- Vale

"Very few doctors today display the confidence in their ability that Dr Mukkamala has. And does this without arrogance. He explains a complicated procedure and is sure that you understand when he finishes. I highly recommend him if you need this type of care."

- David

OPH1004