Clinical Trials

Julie S. Burt
Supervisor, Ophthalmology Clinical Trials and Regulatory Affairs
New England Eye Center
Tufts Medical Center
800 Washington Street, #450
Boston, MA 02111
617-636-0747 Fax: 617-636-4866
Email: jburt@tuftsmedicalcenter.org

Open to enrollment:

Sponsor: Ophthotech
Protocol Name: A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (anti-PDGF Pegylated Aptamer) Given in Combination with Lucentis in Subjects with Neovascular Age-Related Macular Degeneration
Principal Investigator: Adam Rogers, MD
Study Coordinator: Patricia Dizon, 617-636-5489

Age-Related Macular Degeneration
A Phase II, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (anti-PDGF Pegylated Aptamer) Given in Combination with Lucentis in Subjects with Neovascular Age-Related-MacularDegeneration

Target population: Males and females, 50 years and older, with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Description: E10030 is an investigational drug that is being studied and is designed to interrupt the formulation of abnormal blood vessels in age-related macular degeneration. E10030 will be administered in combination with Lucentis which may have the potential to stop or reverse the growth of abnormal blood vessels in the eye and possibly restore vision.

Please contact Patricia Dizon, Clinical Research Coordinator, at 617-636-5489, for further information regarding participation in this study.


Sponsor: Novartis
Age Related Macular Degeneration
Biomarkers for Dry Age-Related Macular Degeneration

Target population:  Males and females, 55 years and older, with age-related macular degeneration

Description:  This study involves two new tests that could detect whether people have a common eye disease called dry age-related macular degeneration, or dry AMD.  These tests may also be useful for monitoring people who already have dry AMD, and deciding whether medication is helping them.

Elias Reichel, MD
Principal Investigator

Please contact Tara Mirto, Clinical Research Coordinator, at 617-636-1051, for further information regarding participation in this study.


Sponsor: Falck Medical Inc.
Protocol Name: The Impact of Intravitreal Injection on Central Retinal Artery Perfusion Pressure
Principal Investigator: Elias Reichel, MD


Study Title:  A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma
Contact name: Patricia Dizon and Tara Mirto
Principal Investigator:  Cynthia Mattox, MD      
Therapeutic Area: Glaucoma/Ophthalmology
Please contact Patricia Dizon, Clinical Research Coordinator, at 617-636-5489 or Tara Mirto at 617-636-1051, for further information regarding participation in this study.

1.  Purpose of Study:
An observational study looking at the effectiveness of different glaucoma treatments including medicines, laser surgery, and other types of surgery

2.  Age Requirements:  18 <

3.  Gender Requirement: Males and females

4.  Inclusion Criteria: Open angle glaucoma who have failed two bottles of glaucoma eye drops including patients with normal-tension glaucoma, pigmentary glaucoma, and pseudoexfoliation

5.  Exclusion Criteria: Patients with no light perception, or otherwise not eligible for further treatment
Patients who have noevascular glaucoma
Patients with uveitis-associated glaucoma
Patients with trauma-induced glaucoma
Patients with corticosteroid-induced glaucoma
Patients with primary angle-closure or angle-closure glaucoma
Patients who have had prior incisional surgery for glaucoma

6. Study Requirements: Four clinic visits over a 12-month period.

7. $10 per completed visit.

Closed to enrollment:

Sponsor: Genentech Harbor
Protocol Name: A Phase III, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of 0.5mg Ranibizumab Administered Monthly or on an As Needed Basis (PRN) in Patients with Subfoveal Neovascular Age-Related Macular Degeneration
Principal Investigator: Elias Reichel, MD
Study Coordinator: Patricia Dizon, 617-636-5489

Sponsor: Pfizer
Protocol Name: A Phase II Prospective, Randomized, Multi-Center, Dose Ranging, Comparator Study Evlauating the Efficacy and Safety of PF04523655 Versus Laser in Subjects with Diabetic Macular Edema
Principal Investigator: Elias Reichel, MD
Study Coordinator: Patricia Dizon, 617-636-5489

Sponsor: Allergan
Protocol Name: A 3-Year, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial to Assess the Safety and Efficacy of 700 ug and 350 ug Dexamethasone Posterior Segment Drug Delivery System )DEX PS DDS Applicator System) in the Treatment of Patients with Diabetic Macular Edema
Principal Investigator: Caroline Baumal, MD
Study Coordinator: Patricia Dizon, 617-636-5489

Sponsor: Genentech-RIDE
Protocol Name: A Phase II, Double-Masked, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus
Principal Investigator: Elias Reichel, MD
Study Coordinator: Tara Mirto, 617-636-1051

Sponsor: Neovista-Cabernet
Protocol Name: A Randomized, Prospective, Active Controlled, Study of the Epi-Rad Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated with Wet Age-Related Macular Degeneration
Principal Investigator: Adam Rogers, MD
Study Coordinator: Tara Mirto, 617-636-1051