Clinical Studies for Patients

There are a number of clinical trials and studies on-going at New England Eye Center. If interested, please call the contact person listed for the specific trial or study.

Retina || Pediatrics || Cornea

Retina Studies

Dry AMD

PI: Michelle Liang, MD

Title: IMPACT/SWAGGER

Sponsor: Boston Image Reading Center

Inclusion Criteria

  • Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA.
  • Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye.
  • Clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents.

Study Length and Visits: 9 Visits every three months over two years

Age Range: >50

Payment: $250 Total: [50$ at screening, V2,4,6 and 8]

Contact: Michael Dixon, 617-636-1051

Pseudophakic Cystoid Macular Edema

Primary Investigator: Elias Reichel, MD

Title: Subconjunctival Aflibercept injection for pseudophakic Cystoid Macular Edema

Sponsor: Regeneron

Inclusion Criteria

  • Diagnosed with pseudophakic CME defined as central retinal thickness (CRT)>300 microns, presence of intraretinal cysts on optical coherence tomography (OCT) and visual acuity <=20/32 with petaloid leakage on fluorescein angiogram and late leakage at the disc.
  • Diagnosed with “recalcitrant” CME, defined as less than a 15% decrease in CRT after at least 6 weeks of topical non-steroidal anti-inflammatory drug 3) Has had cataract surgery in the study eye with posterior chamber or anterior chamber intraocular lens implantation.

Study Length and Visits: 5 Visits: One baseline visit followed by three monthly visits (Months 1-3) and an end of study visit at Month 6.

Age Range: >18

Payment: None

Contact: Michael Dixon, 617-636-1051

Dry Age-Related Macular Degeneration

Primary Investigator: 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
Sponsor: University of Virginia

Brief Summary

This is a phase II study to assess the safety and effectiveness of oral doxycycline (ORACEA®), compared to placebo, to determine if it can slow the progression of geographic atrophy in patients who have dry age-related macular degeneration (AMD).

Inclusion Criteria

Clinical diagnosis of geographic atrophy secondary to dry age-related macular degeneration in at least one eye

Study Length and Visits: 6 study visits over a 25-month period with additional testing

Age Range: 55-85 years

Gender: Both

Payment: None

Contact: Study Coordinator, 617-636-1051

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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. 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. Sylvia Yoo, or Shelley Klein: 617-636-6769

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Cornea Studies

Zoster Eye Disease Study (ZEDS)

PI: Kenneth Kenyon, MD

Title: A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.

Sponsor: NYU/NEI/NIH

Inclusion Criteria

  • Ability to take oral medication, and are willing to adhere to study medication regimen.
  • Diagnosed with HZO in one eye based on both of these criteria:
    • History of characteristic unilateral vesicular rash in the dermatomal distribution of cranial nerve V1.
    • Medical record documentation of an episode of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO within the preceding year. This episode of active anterior segment ocular disease may be due to HZO of recent onset (within the preceding 6 months); or chronic HZO (with onset six or more months ago); may be new, worsening, or recurrent disease after a period of inactivity; and may occur after medication was reduced.
  • For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).

Study Length and Visits: 8 Visits over 18 months

Age Range: >18

Payment: $50 for participation

Contact: Michael Dixon, 617-636-1051

Glaucoma Undergoing Cataracts Surgery

PI: Kamden Kopani, MD

Title: Analysis of the secretome in the aqueous humor from patients undergoing cataract surgery

Sponsor: Novartis

Inclusion Criteria

Patients diagnosed with open angle glaucoma and requiring cataract surgery.

Study Length and Visits: Collection during cataracts surgery
Age Range: 18-90
Payment: None
Contact: Michael Dixon, 617-636-1051

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