Clinical Trials & Studies

Referring Physicians – the following is technical details for your information and in the event you have patients you feel might be appropriate to refer. Please contact the person listed for the specific trial or study, or the lead investigator.


  Retina   ||   Pediatrics   ||   Cornea  


Retina Studies

Geographic Atrophy in Dry AMD

Andre Witkin, MD

Title: A Randomized, Double Masked, Placebo Controlled Study Evaluating ORACEA in Subjects with Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

Brief Summary
To assess the safety and effectiveness of the investigational drug ORACEA®, to determine if it can slow the progression of geographic atrophy in your study eye in participants who have geographic atrophy secondary to non-exudative age-related macular degeneration (dry AMD). 

Inclusion Criteria

  • Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye as confirmed color fundus photography.

Study Requirements
6 study visits over a 25-month period with additional testing
Age Range

55-85

Gender
Both

Payment
None

Contact: Carly Satsuma, 617-636-5489

Age-Related Macular Degeneration (AMD) and Other Macular Disorders

Etiologic Studies of Age Related Macular Degeneration

Principal Investigator: Johanna M. Seddon, MD., ScM

Definition: AMD is a retinal degenerative disease that causes a progressive loss of central vision. AMD is the most common cause of vision loss in individuals age 60 years and older. Juvenile onset forms of macular degeneration, like Stargardt and Best disease, also can cause severe loss of vision.

Target Population: Individuals with macular degeneration (wet or dry) and spouses, siblings and adult children (with or without AMD), including age-related and juvenile onset forms of macular degeneration.

Duration: On-going since 1989.

Purpose: The purpose of this research study is to determine the causes of macular degeneration so we can prevent it and find better treatments. We will continue to identify genes and environmental determinants of macular degeneration. Eligible study participants will have an eye exam and blood draw. Participants will also complete questionnaires on diet and risk factors.

Click Here for full details

YOU DO NOT NEED TO LIVE IN THE BOSTON AREA TO PARTICIPATE.

Contact: Project Manager, Ophthalmic Epidemiology and Genetics Service
New England Eye Center
Tufts Medical Center
800 Washington Street #450
Boston, MA 02111
617-636-9000 or toll free: 800-219-9157

AMD and Macular Dystrophies

Primary Investigator: Johanna Seddon, MD

Title: Genetic and Non-genetic Biomarkers for Macular Degeneration and Macular Dystrophy

Sponsor: NIH

Inclusion Criteria: Dry and Wet AMD, Stargardt, Best, High Myopia, other Macular Dystrophies

Age Range: Any, and normal patients age 65+

Payment: None, but ***Patients do not need to come into Boston to participate***

Contact: Dr. Seddon’s Study Staff: 6-9000

Geographic Atrophy in Dry AMD

Primary Investigator: Nadia Waheed, MD

Title: MAIA 2 Microperimetry in Geographic Atrophy

Sponsor: Johnson & Johnson

Inclusion Criteria: Age-related macular degeneration with geographic atrophy, BCVA of 20/80-20/800, refraction of +10.00D to -8.00D, up to 4.00D of astigmatism

Study Length and Visits: 2 visits within 6 months

Age Range: 55-90

Payment: $100 on completion of 2 visits, Transportation up to an additional $60

Contact: Mildred Commodore, 617-636-1051, Carly Satsuma, 617-636-5489

AMD

Primary Investigator: Nadia Waheed, MD

Title: High-Field MRI of Intracranial Vasculature at MGH

Inclusion Criteria: AMD, No contraindications to MRI Scanning (electrical implants, ferromagnetic implants or objects, weight > 350 lbs, women of childbearing age seeking to become pregnant or may be pregnant, pre-existing medical condition likely to develop seizures or claustrophobic reactions, and greater than normal potential for cardiac arrest)

Study Length and Visits: 1 visit

Age Range: 18+ years

Payment: $150, ***Transportation Provided***

Contact: Carly Satsuma, 617-636-5489, Mildred Commodore, 617-636-1051

Retinal Prosthesis

Primary Investigator: Michelle Liang, MD

Title: Argus II Retinal Prosthesis System Study

Sponsor: Second Sight

Brief Summary
New England Eye Center is now screening patients for the Argus II Retinal Prosthesis System. This is an implant for the eye that can partially restore vision for patients who are blind from Retinitis Pigmentosa.
The Argus II is an electrode implant that receives signals from an external video processing unit and is based on what the patient sees through a video camera housed in special glasses. The video is processed and signals are sent wirelessly to the implant to stimulate the retinal cells and transmit visual information to the brain, creating the perception of patterns of light. Over time, users learn how to interpret these visual patterns as objects and shapes.
While the Argus II System has already been approved by the FDA as a humanitarian use device, New England Eye Center MDs will be studying the long-term effects of this device.

Inclusion Criteria

  • Adult over age 25
  • Bare light or no light perception in both eyes due to Retinitis Pigmentosa
  • Able to see objects, shapes, and lines in the past
  • Willing and able to comply with clinical follow-up, device fitting, and visual rehabilitation

Payment: None

Contact: Carly Satsuma, 617-636-5489



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Pediatrics Studies

Pediatric Amblyopia

Primary Investigator: Vicki Chen, MD

Title: Novel Video Based Therapy for Children with Amblyopia

Inclusion Criteria
Group #1: Age 4-10 years, untreated or minimally treated amblyopia with possible need for patching/atropine, BCVA in amblyopic eye 20/30 to 20/80, 20/30 or better in fellow eye, no previous intraocular or refractive surgery, no coexisting ocular, neurological or systemic disease that could impact visual acuity assessment Group #2: Age 4-15 years, amblyopia, one or more other eye conditions with amblyopic component, BCVA in amblyopic eye 20/30 to 20/80, 20/30 or better in fellow eye

Risk: Minimal, including possible temporary headaches, double vision, eye strain timeframe

Benefit: Alternative treatment to patching/atropine, potential improvement in vision Study Length and Visits: 16 weeks, 4 visits (5 visits including enrollment visit)

Payment: None

Contact: Principal Investigator Dr. Vicki Chen, Co-Investigators Dr. Catherine Choi, Dr. Nicole Quinn, Dr. Mitchell Strominger, Dr. Sylvia Yoo, or Shelley Klein: 617-636-6769

OCTA in Amblyopic Eyes

Primary Investigator: Catherine Choi, MD

Title: Structural Changes in Optical Coherence Tomography Angiography (OCTA) in Amblyopic Eyes

Inclusion/Exclusion Criteria

  • Age 4-12 years with diagnosis of refractive, strabismic, or deprivation amblyopia
  • BCVA in amblyopic eye 20/30 or worse with 2 Snellen line difference from fellow, non-amblyopic eye
  • No previous intraocular or refractive surgery, no coexisting ocular, neurological or systemic disease, no history of prematurity > 8 weeks 

Risk:Minimal, including possible temporary eye strain and photophobia from dilating drops

Benefit:Enhance understanding of anatomic differences associated with amblyopia and assess whether structural changes occur with appropriate treatment

Study Length and Visits: 4 visits total over course of 1 year, at 3 month intervals

Payment: None currently (pending additional funding)

Contact: Principal Investigator Dr. Catherine Choi, Co-Investigators Dr. Vicki Chen, Dr. Nicole Quinn, Dr. David Reese, Dr. Mitchell Strominger, Dr. Sylvia Yoo, or Shelley Klein: 617-636-6769 



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Cornea Studies

Contact Lens Discomfort & Neuropathic Corneal Pain

Primary Investigator: Pedram Hamrah, MD

Title: Assessment of Cellular and Soluble Mediators in Contact Lens Discomfort and Neuropathic Corneal Pain

Sponsor: CooperVision

Brief Summary

Inclusion Criteria

  • Group I (symptomatic CL wearers): over the age of 18, willing and able to commit and consent to IVCM and tear collection, have had daily contact lens wear experience, report a comfortable wearing time (CWT) <8 hours, noticeable reduction in comfort over the course of the day and a score of ≥14 by CLDEQ-8
  • Group II (Asymptomatic CL wearers): over the age of 18, willing and able to commit and consent to IVCM and tear collection and have had daily contact lens wear experience, report a CWT > 10 hours, minimal reduction in comfort over the course of the day (i.e. lens wearing time less CWT < 1hr) and a score of <14 by CLDEQ-8
  • Group III (Intolerant CL wearers): over the age of 18, willing and able to commit and consent to IVCM and tear collection, and have stopped CLW due to discomfort symptoms arising in the first 6 hours of lens wear.
  • Group IV (Neuropathic corneal pain patients): over the age of 18, willing and able to commit and consent to IVCM and tear collection and have neuropathic corneal pain as diagnosed clinically and by IVCM.
  • Group V (Normal subjects): over the age of 18, willing and able to commit and consent to IVCM and tear collection.

Study Length and Visits: 1 to 2 study visits

Age Range: > 18 years old

Payment: $50 for participation

Contact: Mildred Commodore, 617-636-1051 or Carly Satsuma, 617-636-5489

No Dry Eye Disease (DED)

Primary Investigator: Pedram Hamrah, MD

Title:Ocular Surface Immune Response in Dry Eye Disease: Analysis of Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

Sponsor: Allergan

Inclusion Criteria

No eye disease/infection/surgery within the past year, No dry eye symptoms (e.g. itching, burning, light sensitivity), No history of DED or Diabetes, General good health, Does not wear contact lenses or currently use eye medications

Study Length and Visits: One visit

Age Range:  40+ years old

Payment: $50 for participation in study

Contact:Carly Satsuma, 617-636-5489



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