Clinical Studies for Physicians

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

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. 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

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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