Research

Research is an important element of our practice for the physicians of Retina Associates of New Jersey. By participating in clinical trials, we are able to offer more treatment options for patients, some of whom would otherwise have no available treatments. Additionally, we are able to incorporate the knowledge gleaned from these trials into our standard of care in a timely manner. We participated in multiple trials that have led directly to FDA approval of new treatments.

By participating in a clinical trial, a patient can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Two full-time research coordinators administrate the active clinical studies in which Retina Associates of New Jersey is currently participating.

Actively enrolling patients are:
Regeneron VISTA: A study to determine the efficacy of an intravitreally administered VEGF Trap-Eye (BAY86-5321) in patients with Diabetic Macular Edema with central involvement.

Lux Biosciences LX211-11: A study to assess the safety and efficacy of voclosporin gel capsules as therapy in subjects with active noninfectious posterior uveitis.

Santen SAKURA: A study to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic suspension for the treatment of active noninfectious posterior uveitis.

Closed to enrollment, but currently in progress are:
Genentech RISE: A study of the efficacy and safety of ranibizumab (Trade name Lucentis) injections in patients with clinically significant Macular Edema secondary to diabetes mellitus (Type 1 or 2). For preliminary results, please see http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13287

Genentech HARBOR: A dose-comparison study of the efficacy and safety of ranibizumab (Trade name Lucentis) injections in patients with choroidal neovascularization secondary to Age-Related Macular Degeneration.

Genentech SHORE: A study evaluating dosing regimens for treatment with ranibizumab (Trade name Lucentis) injections in patients with Macular Edema following Retinal Vein Occlusion (branch or central).

Pfizer NAION : The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including sildenafil (Trade name Viagra), vardenafil (Trade name Levitra), or tadalafil (Trade name Cialis), triggers the onset of acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).

RETAIN: This study evaluates long-term safety in patients with Macular Edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.

Significant trials we have participated in previously are:
ThromboGenics MIVI-TRUST: Investigated the intravitreal injection of Ocriplasmin for treatment of symptomatic vitreomacular adhesion.
Published results: Krader, Cheryl Guttman. Steven D. Schwartz, MD, ed. Ocriplasmin treats sVMA. OpthamologyTimes. 2011 April 15:39-40.
http://thrombogenics.com/wp-content/uploads/2011/03/OT_Ocriplasmin_Schwartz_4-11.pdf

Alimera FAME: A study of the safety and efficacy of fluocinolone acetonide intravitreal insert (Iluvien, Alimera Sciences) for treatment of DME.
Published results: Pearson, P. Andrew, MD. Fluocinolone Insert’s Impact on Overall Risk of Procedures: In an analysis of FAME study data, risk of subsequent procedures was reduced in treated patients. Retina Today. 2010 October:72-74. http://bmctoday.net/retinatoday/pdfs/1010RT_Feature_Pearson.pdf

Genentech BRAVO/CRUISE: To assess the efficacy and safety of intraocular injections of Ranibizumab (Trade name Lucentis) in patients with macular edema after central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO).
Published results for CRUISE: Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators (including Frenkel, REP). Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.
http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(10)00186-7/abstract
Published results for BRAVO: Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators (including Frenkel, REP). Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1.
http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(10)00185-5/abstract

NIH SCORE A study for the comparison of Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) compared the safety and effectiveness of standard care laser treatment with two different doses of triamcinolone (Trade name Kenalog) injections for the treatment of Retinal Vein Occlusion.
Published results: Domalpally A, Blodi BA, Scott IU, Ip MS, Oden NL, Lauer AK, VanVeldhuisen PC and the SCORE Study Investigator Group. The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study System for Evaluation of Optical Coherence Tomograms: SCORE Study Report 4. Arch Ophthalmol. 2009;127(11):1461-1467. http://www.nei.nih.gov/news/pressreleases/091409a.asp http://www.nei.nih.gov/news/pressreleases/091409b.asp

Genentech ANCHOR: A study for the comparison of Ranibizumab (Trade name Lucentis) versus Verteporfin (Trade name Visudyne) Photodynamic Therapy for Neovascular Age-Related Macular Degeneration. This trial, along with the MARINA trial, was pivotal in the FDA approval of Lucentis for Wet AMD.
Published results: Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus Verteporfin for neovascular Age-Related Macular Degeneration. New England Journal of Medicine. 2006 Oct 5;355(14):1432-44. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=PureSearch&db=pubmed&term=17021319%5BUID%5D