Clinical Trials

The following clinical trials are on-going at New England Eye Center. If interested, please call the contact person listed for the specific study. You also may contact Shana Haynes-Harp, Manager, Ophthalmology Clinical Trials and Regulatory Affairs at 617-636-0747 or by email: shaynes1@tuftsmedicalcenter.org.

Retina Ophthalmology

Andre Witkin, MD

Title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study To Assess The Efficacy And Safety Of Lampalizumab Administered Intravitreally To Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration

Brief Summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Inclusion Criteria

  • Participants aged >/= 50 years
  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Study Requirements
2 year study with additional testing

Age Range
50 and over

Gender
Both

Payment
None

Transportation provided


Contact: Carly Satsuma, 617-636-5489


Retina Ophthalmology

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

  • Participants aged 50-85 years
  • 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
8 study visits over a 31 month period with additional testing
Age Range

55-85

Gender
Both

Payment
None

Transportation provided

Contact: Carly Satsuma, 617-636-5489


Retina Ophthalmology

Caroline Baumal, MD

Title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center Study to Compare the Efficacy and Safety of a Chemokine CCR2/5 Receptor Antagonist (PF-04634817) with that of Ranibizumab in Adult Subjects with Diabetic Macular Edema

Brief Summary
To compare the effects of the study drug, PF-04634817, which is a tablet taken by mouth, with ranibizumab to find out whether PF-04634817 is useful for treating Diabetic Macular Edema

Inclusion Criteria

  • Participants aged 18 and above
  • Clinical diagnosis of diabetes mellitus (type 1 or 2) with stable medication for the management of diabetes for at least 3 months before randomization and expected to remain stable during the study.

Study Requirements
6 study visits over a 16 week period with additional testing

Age Range
18+

Gender
Both

Payment
None

Transportation provided

Contact: Greg Dellapenna, 617-636-1051


Retina Ophthalmology

Adam Rogers, MD

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 Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

Brief Summary
To evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Inclusion Criteria

  • Subjects of either gender aged ≥ 50 years
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Presence of sub-retinal hyper-reflective material (SD-OCT)

Study Requirements
26 study visits over a 2 year study period with additional testing

Age Range
50 years and older

Gender
Both

Payment
None

Transportation provided

Contact: Carly Satsuma, 617-636-5489


Retina Ophthalmology

Andre Witkin, MD

Title: A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

Brief Summary
To assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).

Inclusion Criteria

  • Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
  • Aged 50 years or older
  • Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Study Requirements
26 study visits over a 2 year period, additional testing involved

Age Range
55 and over

Gender
Both

Payment
None

Contact: Greg Dellapenna, 617-636-1051


Retina Ophthalmology

Adam Rogers, MD

Title: Ocriplasmin Research to Better Inform Treatment (ORBIT)

Brief Summary
To assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

Inclusion Criteria

  • Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label.

Study Requirements
1 year study period, additional testing involved

Age Range
18 and over

Gender
Both

Payment
None

Contact: Carly Satsuma, 617-636-5489


Retina Ophthalmology

Andre Witkin, MD

Title: Eplerenone for the Treatment of Central Serous Chorioretinopathy

Brief Summary
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Inclusion Criteria

  • Age 18 and over
  • Ability to give written informed consent
  • Sub-retinal fluid under fovea seen on OCT
  • Diagnosis of CSCR: classification is at the discretion of the investigator, but general guidelines are
    • Acute- first episode or symptoms less than one month prior to presentation
    • Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.

Study Requirements
4 study visits within a 1 month period

Age Range
18 and over

Gender
Both

Payment
None

Contact: Greg Dellapenna, 617-636-1051


Retina Ophthalmology

Elias Reichel, MD

Title: Intervention Study to Assess the Effect of Daily Consumption of a Lutein-enriched-egg Beverage on Maintenance of Visual Function in Subjects With Early Signs of Age-related Macular Degeneration

Brief Summary
To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.

Inclusion Criteria

  • Early AMD (AREDS category 2)
    • many small drusen, or
    • a few intermediate-sized (63-124 micrometres in diameter) drusen, or
    • macular pigmentary changes

                      Or

  • Intermediate AMD (AREDS category 3)
    • extensive intermediate sized (63-124 micrometres in diameter) drusen, or
    • at least one large (>125 micrometers in diameter) drusen or
    • geographic atrophy not involving the foveal centre

Study Requirements
3 study visits over a 1 year study period

Age Range
50 and over

Gender
Both

Payment
Patient stipend of $200 per study visit provided

Contact: Carly Satsuma, 617-636-5489