Clinical Research

Delaware Valley Retina Associates has an established history of conducting clinical trials as part of our commitment to offering our patients the most innovative and current treatment options available. We work cooperatively with study participants and drug company sponsors and have been on the forefront of many landmark treatments for age-related macular degeneration (AMD), diabetic retinopathy, retinal vein occlusion and vitreomacular traction. We offer patients the opportunity to participate in clinical trials conducted at our Lawrenceville facility under the guidance of our experienced clinical study coordinators who work in partnership with patients and our physicians.

To learn about current or upcoming studies, please contact our main office and ask to speak with one of our study coordinators. Please be aware that patients must meet certain criteria in order to be trial eligible.

Completed Studies

 

Macular Degeneration

Marina (2003)

Study Sponsor: Genentech

One of the original studies using Ranibizumab (Lucentis) for the treatment of neovascular age-related macular degeneration (AMD). Dosages of the drug were either 0.3mg or 0.5mg.

Outcome: Monthly eye injections maintained vision in 90-95% of patients after 2 years. Improved vision was maintained in 25% of patients taking 0.3mg dosage and 34% of patients taking the 0.5mg dosage.

Anchor (2003)

Study Sponsor: Genentech

Ranibizumab (Lucentis) verses Verteportin (Visudyne) for the treatment of neovascular AMD. Randomized to photodynamic therapy (PDT) plus sham injection or to placebo PDT and 0.3mg injection of Ranibizumab (Lucentis).

Outcome: Vision was maintained in 94% of patients with 0.3mg dosage of Lucentis and 96% in 0.5 dosage of Lucentis vs. 64% in PDT group. Vision improved by 9 letters on the eyechart in the 0.3mg group and 11 letters in the 0.5mg group.

Sailor (2006)

Study Sponsor: Genentech

Safety assessment of Ranibizumab (Lucentis) for AMD using two groups (cohorts). Cohort 1: 0.3mg or 0.5mg at 3-month dosing intervals. Retreatment based on Optical Coherence Tomography (OCT) results. Cohort 2: 0.5mg dosage and retreatment based on physician discretion.

Outcome: Patients who were treatment-naive gained more eye chart letters in the 0.5mg group than the 0.3mg group. Previously treated patients gained more eye chart letters than treatment-naive patients (more improvement in the 0.5mg recipients than the 0.3mg recipients.)

Horizon (2009)

Study Sponsor: Genentech

Open label extension trial of Ranibizumab (Lucentis) for choroidal neovascularization secondary to AMD.

Outcome: Initial increase in visual acuity decreased by about 8 eye chart letters with dosing less frequently in the third and fourth year.

Harbor (2009)

Study Sponsor: Genentech

Examination of either 0.5mg or 2mg of Ranibizumab (Lucentis) for neovascular AMD either given monthly or as needed.

Outcome: After 3 monthly doses, patients receiving as-needed dosing maintained their visual acuity through month twelve. Patients receiving monthly doses gained 1 to 2 additional letters on the eye chart.

Regeneron VGFT-OD-0605 (Eylea) (2007)

Study Sponsor: Regeneron

Study of the efficacy, safety and tolerability of VEGF-trap for neovascular AMD.

Outcome: Visual gains were sustained with a less-than-monthly dose.

AREDS 2 (2006)

Study Sponsor: National Eye Institute

A trial of lutein/zeaxantin and omega-3 added to an original eye vitamin formula to determine if these are beneficial in keeping dry AMD from progressing to neovascular AMD.

Outcome: There is no benefit with the addition of Omega-3 to the original AREDS formula. The addition of lutein is beneficial for those who lack lutein (found in green, leafy vegetables) in their diet.

Retinal Vein Occlusion

BRAVO (2007)

Study Sponsor: Genentech

A study of the efficacy and safety of Ranibizumab (Lucentis) in patients with macular edema secondary to branch retinal vein occlusion.

Outcome: Ranibizumab (Lucentis) was successful in treating macular edema secondary to branch retinal vein occlusion.

SCORE (2004)

Study Sponsor: National Eye Institute

Standard care (laser) vs. corticosteroids (either a 1mg dose or a 4mg dose) for the treatment of both central retinal vein occlusion and branch retinal vein occlusion.

Outcome: Patients with central retinal vein occlusion who received steroid injections had a better visual improvement for up to 2 years. However, the higher dose had a higher rate of adverse events including cataracts and elevated intraocular pressure. Branch retinal vein occlusion patients had better visual outcome for up to 3 years but suffered the same adverse events. It was concluded that laser was safer with fewer side effects than steroids.

Diabetic Macular Edema

RIDE (2007)

Study Sponsor: Genentech

A study to evaluate the efficacy and safety of Ranibizumab (Lucentis) injections in treating diabetic macular edema.

Outcome: Successful in treating diabetic macular edema at a dose of 0.3mg.

Posurdex (Ozurdex) (2010)

Study Sponsor: Allergan

A study to evaluate the efficacy of an intravitreal injection of a steroid implant for treatment of diabetic macular edema.

Outcome: Effective in improving visual acuity and decreasing diabetic macular edema.

Vitreomacular Traction

Thrombogenics (Jetrea) (2009)

Study Sponsor: Thrombogenics

A study to evaluate the efficacy of an intravitreal injection of microplasmin for the treatment of vitreomacular traction as opposed to surgical intervention.

Outcome: Successful in dissolving the fibers which cause vitreous strands to pull on the macula often resulting in a macular hole. Once the fibers are dissolved, the strands successfully detach from the macula.


Ongoing Studies But Not Recruiting

 

Regeneron VGFT-AMD-1124 (Eylea) (2012)

Study Sponsor: Regeneron

A study of the efficacy and safety of VEGF-Trap intravitreal injections for treatment of neovascular AMD.


Currently Recruiting

 

Eclipse (Fovista) (2013)

Study Sponsor: Ophthotech

A study to determine the safety and efficacy of intravitreal injections of Fovista administered in combination with Lucentis compared to Lucentis monotherapy for the treatment of age-related macular degeneration.

SCORE2 (2014)

Study Sponsor: National Eye Institute

A 12-month trial comparing intravitreal bevacizumab (Avastin) every 4 weeks with intravitreal aflibercept (Eylea) every four weeks for the treatment of central retinal vein occlusion.

ORBIT (2014)

Study Sponsor: ThromboGenics

The purpose of this trial is to observe clinical outcomes and safety in patients receiving JETREA for the treatment of symptomatic vitreomacular adhesion.

TOGA (2014)

Sponsor: University of Virginia

A randomized, double-masked, placebo-controlled study evaluating ORACEA in subjects with geographic atrophy secondary to non-exudative age-related macular degeneration. This study will evaluate the safety and efficacy of daily administration of oral ORACEA compared to a placebo, to determine if it can slow the progression of geographic atrophy secondary to dry age-related macular degeneration.

Chroma (2014)

Study Sponsor: Genentech

A study to assess the efficacy and safety of lampalizumab administered to patients with bilateral geographic atrophy secondary to non-exudative (dry) macular degeneration.