Research

Research

CURRENT TRIALS: OPEN FOR ENROLLMENT OR FOLLOWING PATIENTS 

Age Related Macular Degeneration “ AMD 

TOGA-¯University of Virginia (TOGA)-Dry AMD with Geographic Atrophy”A Phase II/III Study of ORACEA in Patients with Geographic Atrophy.  This is a multiple-center, randomized, placebo-controlled study.  Only one eye will be selected as the study eye.  Study eye must has no history of wet AMD.  Fellow eye must have no treatment for wet AMD in past 12 months.   https://www.clinicaltrials.gov/ct2/show/NCT01782989?term=toga&rank=4

JANSSEN (PRELUDE)- Dry AMD with Geographic Atrophy- A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of¯CNTO 2476¯in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration¯https://clinicaltrials.gov/ct2/show/NCT02659098?term=Dry+Macular+Degeneration&recr=Open&state1=NA%3AUS%3AKY&age=1&rank=3 

Genentech LADDER  GX 28228- Exudative¯AMD with previous treatment and diagnosis within 5 months or even new Wet AMD patients that have not had treatment but need treatment.¯ 

https://clinicaltrials.gov/ct2/show/NCT02510794?term=Wet+Macular+Degeneration&recr=Open&state1=NA%3AUS%3AKY&age=1&rank=3 

 

Diabetic Macular Edema  

Roche (BOULEVARD)- A Phase 2 Study of RO6867461 in Participants With Center-Involving Diabetic Macular Edema (CI-DME) This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 28-week study in participants with -DME. Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. Participants will be randomized into each arm group (1:1:1) and total duration of the study will be approximately 32 weeks. https://clinicaltrials.gov/ct2/show/NCT02699450?term=Roche+DME&rank=1 

Diabetic Retinopathy 

 

Regeneron (PANORAMA)- VGFTe-OD-1411- A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy. The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR). https://clinicaltrials.gov/ct2/show/NCT02718326?term=regeneron+1411&rank=1 

 


 
PREVIOUS CLINICAL TRIALS: COMPLETED 

AGE-RELATED MACULAR DEGENERATION (AMD) 

ROLL Study:¯¯A Phase 4 Investigator Sponsored Trial (IST) utilizing intravitreal Eylea (aflibercept) in patients with persistent pigment epithelia detachment (PED) in neovascular AMD (Active, enrollment closed). 

ForeseeHome Device Study/Notal Vision:¯ A study to assess the accuracy of the ForeseeHome home monitoring device to detect the presence of wet AMD following the successful treatment with anti-VEGF therapy such as Avastin, Lucentis, or Eylea¯ (Active, enrollment closed). 

AREDS II Study:¯¯A 5-year study sponsoerd by the National Eye Institute (NEI), a branch of the National Institutes of Health (NIH), to evaluate the benefit of omega-3 fatty acid (fish oil) supplementation as well as carotenoid (lutein and zeaxanthin) usage in addition to the original AREDS¯ (Completed).¯¯Results available June 2013. 

HiPED Study: IST (Investigator Sponsored Trial) evaluating high dose Lucentis for persistent pigment epithelial detachment in neovascular AMD (Completed; results presented by Retina Associates of Kentucky at ARVO 2012, ASRS 2012, and AAO 2012 meetings). 

HARBOR Study: A national, randomized prosepctive clinical trial evaluating standard dose Lucentis (0.5 mg) and high-dose Lucentis (2.0 mg) for the treatment of wet AMD (Completed). 

HORIZON study:¯ Open-label extension study of the safety and efficacy of intravitreal Lucentis for the treatment of wet AMD. (Completed). 

Pharmacogenetics of Wet AMD Treatment Response Study: IST (Investigator Sponsored Trial) evaluating the role of genetics on response to anti-VEGF therapy (Completed; results presented by Retina Associates of Kentucky at ASRS 2011 and awarded best research poster). 

CATT Study (Comparison of Age-related Macular Degeneration Treatment Trials):¯ NIH-sponsored randomized, controlled comparitive effectiveness trial comparing the safety, effectiveness and treatment intervals of Lucentis versus Avastin injections for the treatment of wet AMD (Completed)www.med.upenn.edu/cpob/studies/CATT.shtml. 

Denali Study:¯ Randomized, double-masked, sham controlled study to evaluate safety and efficacy of combination therapy of Photodynamic Therapy (PDT) and Lucentis vs Lucentis only for wet AMD (Completed). 

Veritas Study: A randomized, double-masked, sham controlled, multicenter, phase III-B study comparing photodynamic therapy (PDT) plus two different dose regimens of intravitreal steroid (triamcinolone 1mg and 4 mg) versus PDT plus intravitreal Macugen in patients with wet AMD (Completed). 

Alcon C-04-59 Study:¯¯A national collaborative study of 15 mg Anecortave Acetate administered every 3 months versus 15 mg Anecortave Acetate administered every 6 months versus 30 mg of Anecortave Acetate administered every 6 months with for patients with wet AMD (Completed). 

Alcon C-02-60 Study:¯ A national collaborative study of Anecortave Acetate versus sham for the prevention of wet macular degeneration (Completed). 

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Diabetic Retinopathy or Diabetic Macular Edema 

Diabetic Retinopathy Clinical Research ¯Network - Protocol T:¯ A comparative effectiveness study comparing Intravitreal Eylea (aflibercept), Avastin (bevacizumab) and Lucentis (ranibizumab) for diabetic macular edema (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol R:¯ Phase II randomized trial of topical nonsteroidal eye drops for non-center involved diabetic macular edema (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol N: A randomized clinical trial evaluatting intravitreal Lucentis for vitreous hemorrhage due to proliferative diabetic retinopathy (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol M:¯ A prospective study evaluating the effect of diabetes education during office visits on blood sugar control and progression of diabetic retinopathy (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol K:¯ Laser Response Study (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol I:¯ A randomized clinical trial evaluating grid laser vs Lucentis (ranibizumab) vs intravitreal steroid (triamcinolone) and laser for diabetic macular edema (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol H:¯ A study comparing intravitreal Avastin for diabetic macular edema (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol G:¯ An observational study on the progression of subclinical diabetic macular edema to clinically significant macular edema (Completed; results presented by Retina Associates of Kentucky at ARVO 2010). (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol D:¯ A study evaluating the benefits of vitrectomy for diabetic macular edema (Completed). 

Diabetic Retinopathy Clinical Research Network - Protocol B:¯ A randomized clinical trial comparing intravitreal steroid to grid laser therapy for diabetic macular edema (Completed). 

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Retinal Vein Occlusion 

SCORE 2 Study: A multicenter, prospective, randomized, phase III clinical trial in which all participants enrolled will be followed for 12 months. SCORE2 is designed as a non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every 4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at Month 6 https://clinicaltrials.gov/ct2/show/NCT01969708 

BRAVO Study:¯ A randomized, phase III trial evaluating the efficacy and safety of Lucentis versus grid laser in subjects with macular edema secondary to Branch Retinal Vein Occlusion (Completed). 

CRUISE Study: A randomized, pahse III trial evaluating the efficacy and safety of Lucentis versus sham (observation) in subjects with macular edema secondary to Central Retinal Vein Occlusion (Completed). 

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Ocular Histoplasmosis 
Intravitreal Aflibercept Injection for the Treatment of Presumed Ocular Histoplasmosis Syndrome-Related Choroidal Neovascularization Investigator Sponsored Trial. HANDLE STUDY (Completed). 

Lucentis for Ocular Histoplasmosis Syndrome (LOHS) Study:¯IST (Investigator Sponsored Trial) evaluating Lucentis for treatment of choroidal neovascularization secondary to ocular histoplasmosis syndrome (Completed).¯