Current Trials Lexington | Research Ashland | Retina Associates Kentucky

Research

CURRENT STUDIES (Open for Enrollment or Enrolling Soon!):

AGE-RELATED MACULAR DEGENERATION (AMD):

TENAYA GR40306 Study (Hoffmann-La Roche): A phase III study to evaluate the efficacy, safety, durability, and pharmacokinetics of intravitreal faricimab administered at 8-week intervals, or as specified in the protocol following treatment initiation, compared with aflibercept (Eylea) once every 8 weeks in participants with neovascular age-related macular degeneration. [https://clinicaltrials.gov/]

OAKS APL-2-304 Study (Apellis Pharmaceuticals, Inc.): A phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of intravitreal injections of APL-2 in subjects with GA secondary to AMD. [https://clinicaltrials.gov/]

SAGA Alk-001 Study (Alkeus Pharmaceuticals, Inc.): This is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of ALK-001 in participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo. [https://clinicaltrials.gov]

DIABETIC RETINOPATHY (DR):

New studies coming soon.

UVEITIS:

LUMINA Study (Santen Inc.): A Phase III study to assess the efficacy and safety of intravitreal DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye. [https://clinicaltrials.gov/]

FORMER STUDIES (Closed to Enrollment, Following Patients or Completed):

AGE-RELATED MACULAR DEGENERATION (AMD):

ARCHWAY GR 40548 Study (Hoffmann-La Roche): A phase III, multicenter, randomized, active treatment-controlled study of the efficacy and safety of the Port Delivery System implant for sustained delivery of ranibizumab (Lucentis) in patients with wet AMD (Enrollment complete, results pending). [https://clinicaltrials.gov/]

PORTAL GR40549 Study (Hoffmann-La Roche): A phase III, multicenter, study of the efficacy and safety of the Port Delivery System for sustained delivery of ranibizumab (Lucentis) in patients with wet AMD. This is an extension of the LADDER phase II study which allows patients who were in the control group to receive the PDS implant (Enrollment complete, results pending). [https://clinicaltrials.gov/]

LADDER GX 28228 Study (Genentech, Inc.): A phase II, multicenter, randomized, active treatment-controlled study of the efficacy and safety of the Port Delivery System for sustained delivery of ranibizumab (Lucentis) in patients with wet AMD (Complete). [https://clinicaltrials.gov/]

TOGA Study (University of Virginia, MEDARVA Foundation): A phase II/III multiple-center, randomized, placebo-controlled study of Oracea (doxycycline) in patients with geographic atrophy due to dry AMD (Enrollment complete, results pending). [https://clinicaltrials.gov/]

CNTO 2476 (PRELUDE) Study (Janssen Research & Development, LLC.): A Phase IIb, 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 dry AMD (Enrollment terminated). [https://clinicaltrials.gov/]

LAMPA GX 29176 Study (Hoffmann-La Roche): A phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy secondary to age-related macular degeneration (Completed). [https://clinicaltrials.gov/]

OMASPECT GX 30191 Study (Hoffmann-La Roche): This multicenter open-label extension study was designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to dry AMD who completed 96 weeks of treatment in studies GX29176 (NCT02247479) or GX29185 (NCT02247531). [https://clinicaltrials.gov/]

CAPELLA REGN2176-3 Study (Regeneron Pharmaceuticals): A phase II, double-masked, randomized, controlled, multiple-dose, regimen-ranging study of the efficacy and safety of intravitreal REGN2176-3 [a coformulation of aflibercept (Eylea) and rinucumab (a PDGFR-beta inhibitor)] vs Eylea monotherapy in patients with wet AMD (Study terminated). [https://clinicaltrials.gov/]

ECLIPSE E10030 Study (Ophthotech Corporation): A phase III clinical trial evaluating the safety and efficacy of intravitreal Fovista (a PDGF inhibitor) in combination with ranibizumab (Lucentis) vs Lucentis monotherapy for the treatment wet AMD (Completed). [https://clinicaltrials.gov/]

ROLL Study (Tennessee Retina, Regeneron Pharmaceuticals): A Phase 4 Investigator Sponsored Trial (IST) utilizing intravitreal Eylea (aflibercept) in patients with persistent pigment epithelial detachment (PED) in neovascular AMD (Completed). [https://clinicaltrials.gov/]

ForeseeHome Device Study (Notal Vision): A study to assess the accuracy of the ForeseeHome monitoring device in detecting the onset of wet AMD in AREDS2 study patients at high risk (Completed). [https://clinicaltrials.gov/]

AREDS II Study [National Eye Institute (NEI), a branch of the National Institutes of Health (NIH)]: A 5-year study 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 formula (Completed). [https://clinicaltrials.gov/]

AREDS II 10-year Follow On Study [National Eye Institute (NEI)]: This is an extension of the multicenter, randomized trial of lutein, zeaxanthin and omega-3 polyunsaturated fatty acids in the AMD AREDS II Study. [https://clinicaltrials.gov/]

HiPED Study: IST (Investigator Sponsored Trial) evaluating high dose ranibizumab (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). [https://clinicaltrials.gov/]

HARBOR Study (Genentech, Inc.): A randomized, prospective clinical trial evaluating standard dose (0.5 mg) ranibizumab (Lucentis) and high-dose (2.0 mg) Lucentis for the treatment of wet AMD (Completed). [http://clinicaltrials.gov]

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 (Comparison of Age-related Macular Degeneration Treatment Trials) Study [National Institutes of Health (NIH)]: A randomized, controlled trial comparing the safety, efficacy, and treatment intervals of intravitreal ranibizumab (Lucentis) versus bevacizumab (Avastin) for the treatment of wet AMD (Completed). [https://clinicaltrials.gov/]

CATT Follow-Up Study [National Institutes of Health (NIH)]: An observational study of patients that participated in the original Comparision of AMD Treatment Trial (Completed).

DENALI Study (Novartis Pharmaceuticals): Randomized, double-masked, sham controlled study to evaluate safety and efficacy of combination therapy of Photodynamic Therapy (PDT) and ranibizumab (Lucentis) vs Lucentis monotherapy for wet AMD (Completed). [http://clinicaltrials.gov]

VERITAS Study (Novartis Pharmaceuticals): A randomized, double-masked, sham-controlled, multicenter, phase III-B study comparing photodynamic therapy (PDT) plus two different dose regimens (1mg and 4 mg) of intravitreal steroid (triamcinolone acetonide) versus PDT plus intravitreal pegaptanib (Macugen) in patients with wet AMD (Completed). [https://clinicaltrials.gov/]

C-04-59 Study (Alcon): 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). [http://clinicaltrials.gov]

C-02-60 Study (Alcon): A national collaborative study of anecortave acetate versus sham for the prevention of wet macular degeneration (Completed). [http://clinicaltrials.gov]

C-01-99 Study (Alcon): A national collaborative study of anecortave acetate vs photodynamic therapy (PDT) for wet AMD (Completed). [https://clinicaltrials.gov/]

EOP 1006 Study (Eyetech Pharmaceuticals): A national collaborative study of the safety, tolerability and pharmacokinetics of 1 mg vs. 3 mg of pegaptanib sodium (a pegylated aptamer) in patients with wet AMD (Completed). [https://clinicaltrials.gov/]

VisIT Study (Novartis Pharmaceuticals): A national collaborative study of PDT vs triamcinolone acetonide or sham for wet AMD (2004).

Limited Retinal Translocation vs Photodynamic Therapy for the Treatment of age-related macular degeneration (2001-2002).

Submacular Surgery Trial: A randomized pilot trial of laser photocoagulation vs surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration. Submacular Surgery Trial Pilot Study report number 1: Ophthalmic outcomes. [Am J Ophthalmol 200;130:387-407]

Submacular Surgery Trial: A randomized pilot trial of laser photocoagulation vs. surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration. Submacular Surgery Trials Pilot Study report number 2: Quality of life outcomes. [Am J Ophthalmol 2000;130:4080-4818]

DIABETIC RETINOPATHY (DR):

YOSEMITE GR40349 Study (Hoffmann-La Roche): A phase III study to evaluate the efficacy, safety, and pharmacokinetics of intravitreal faricimab administered at 8-week intervals, or as specified in the protocol following treatment initiation, compared with aflibercept (Eylea) once every 8 weeks in participants with diabetic macular edema (DME). (Enrollment complete, results pending). [https://clinicaltrials.gov/]

TIME-2b Study (Aerpio Therapeutics): A phase II study to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15 mg once daily or 15 mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (Enrollment complete, results pending). [https://clinicaltrials.gov/]

BOULEVARD BP30099 Study (Hoffmann-La Roche): A phase II study of the safety, tolerability, pharmacokinetics, and efficacy of intravitreal RO6867461 in participants with center-involving diabetic macular edema (CI-DME). This was a multicenter, multidose (1.5 mg and 6 mg), randomized, active comparator-controlled [ranibizumab (Lucentis)], double-masked, 36-week study in participants with CI-DME (Completed). [https://clinicaltrials.gov/]

PANORAMA VGFTe-OD1411 Study (Regeneron Pharmaceuticals): A phase III, double-masked, randomized study of the efficacy and safety of intravitreal aflibercept Injection in patients with moderately severe to severe non-proliferative diabetic retinopathy (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol B: A randomized clinical trial comparing intravitreal steroid (triamcinolone acetonide) to grid laser therapy for diabetic macular edema (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol D: A study evaluating the benefits of vitrectomy for diabetic macular edema (Completed). [https://clinicaltrials.gov/]

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

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol H: A phase II study evaluating intravitreal bevacizumab (Avastin) for diabetic macular edema (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol I: A randomized clinical trial evaluating grid laser vs ranibizumab (Lucentis) vs intravitreal steroid (triamcinolone acetonide) plus grid laser for diabetic macular edema (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol K: A study to evaluate the response, as measured by Optical Coherence Tomography (OCT), to focal laser photocoagulation in diabetic macular edema (DME) patients (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) 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). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol N: A randomized clinical trial evaluating intravitreal ranibizumab (Lucentis) for vitreous hemorrhage due to proliferative diabetic retinopathy (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol R: A phase II randomized trial of topical nonsteroidal eye drops for non-center involved diabetic macular edema (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol S: A study comparing panretinal photocoagulation (PRP) to intravitreal ranibizumab (Lucentis) plus deferred PRP for proliferative diabetic retinopathy (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol T: A comparative effectiveness study comparing Intravitreal aflibercept (Eylea), bevacizumab (Avastin) and ranibizumab (Lucentis) for diabetic macular edema (Completed). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol V: The primary objective of the protocol is to compare the percentage of eyes that have lost at least 5 letters of visual acuity at 2 years with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive either (1) prompt focal/grid photocoagulation + deferred intravitreal aflibercept (Eylea), (2) observation + deferred intravitreal Eylea, or (3) prompt intravitreal Eylea (Enrollment complete, results pending). [https://clinicaltrials.gov/]

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol AA: A natural history study of diabetic retinopathy using ultra widefield retinal imaging (Enrollment complete, results pending).

Diabetic Retinopathy Clinical Research (DRCR) Network – Protocol AD: An ancillary eye study to the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study. Patients with diabetic retinopathy (DR) treated with pemafibrate or placebo will be evaluated for progression of their DR (Ongoing). [https://clinicaltrials.gov/]

RETINAL VEIN OCCLUSION (RVO):

SAPPHIRE Study (Clearside Biomedical, Inc.): A randomized, masked, controlled phase III trial to study the safety and efficacy of suprachoroidal CLS-TA (triamcinolone acetonide) in conjunction with intravitreal aflibercept (Eylea) in subjects with retinal vein occlusion (Completed). [https://clinicaltrials.gov/]

SCORE 2 Study: A multicenter, prospective, randomized, phase III non-inferiority study comparing intravitreal bevacizumab (Avastin) every 4 weeks to intravitreal aflibercept (Eylea) every 4 weeks for the treatment of macular edema associated with central retinal vein occlusion (Completed). [https://clinicaltrials.gov/]

BRAVO Study (Genentech, Inc.): A randomized, phase III trial evaluating the efficacy and safety of ranibizumab (Lucentis) versus grid laser in subjects with macular edema secondary to branch retinal vein occlusion (Completed). [http://clinicaltrials.gov]

CRUISE Study (Genentech, Inc.): A randomized, phase III trial evaluating the efficacy and safety of ranibizumab (Lucentis) versus sham in subjects with macular edema secondary to central retinal vein occlusion (Completed). [http://clinicaltrials.gov]

HORIZON study (Genentech, Inc.): This study evaluated the long-term safety of intravitreal ranibizumab (Lucentis) in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials (Completed). [https://clinicaltrials.gov/]

OCULAR HISTOPLASMOSIS (OHS):

Intravitreal Aflibercept Injection for the Treatment of Presumed Ocular Histoplasmosis Syndrome-Related Choroidal Neovascularization (HANDLE): IST (Investigator Sponsored Trial) evaluating Eylea for treatment of choroidal neovascularization secondary to ocular histoplasmosis syndrome (Completed). [https://clinicaltrials.gov/]

Lucentis for Ocular Histoplasmosis Syndrome (LOHS) Study (Retina Associates of Kentucky; Genentech, Inc.): IST (Investigator Sponsored Trial) evaluating Lucentis for treatment of choroidal neovascularization secondary to ocular histoplasmosis syndrome (Completed). [https://clinicaltrials.gov/]

Visual Acuity & OCT outcomes in patients treated with bevacizumab for Presumed Ocular Histoplasmosis Syndrome (Retina Associates of Kentucky). [IOVS Journal]

Laser Photocoagulation for Subfoveal Ocular Histoplasmosis, a pilot study (1988-1992).

VITREOMACULAR TRACTION (VMT) AND MACULAR HOLE (MH):

ORBIT Study (ThromboGenics): A multicenter, prospective, observational, phase IV study to assess clinical outcomes and safety of ocriplasmin (Jetrea) administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (Completed). [https://clinicaltrials.gov/]

Vitrectomy for Prevention of Macular Holes: A national collaborative study evaluating vitrectomy for management of stage I macular holes (1989-1993).

Vitrectomy for Macular Holes: A national collaborative study evaluating vitrectomy for management of full thickness macular holes (1991-1993).

Silicone Oil Study (NEI): A national collaborative study evaluating long-acting gases and silicone oil in the management of complicated retinal detachments (1990-1994).

ASHLAND

1700 Winchester Avenue
Ashland, Kentucky 41101
Toll Free: (800) 627-2020
Phone: (859) 263-3900
Main Fax: (859) 263-3757
Scheduling Fax: (859) 264-2911

LEXINGTON

120 North Eagle Creek Drive
Suite 500
Lexington, Kentucky 40509
Toll Free: (800) 627-2020
Office: (859) 263-3900
Main Fax: (859) 263-3757
Scheduling Fax: (859) 264-2911

LOUISVILLE

6420 Dutchmans Parkway
Suite 70
Louisville, Kentucky 40205
Toll Free: (800) 627-2020
Office: (502) 895-2600
Main Fax: (502) 895-4002
Scheduling Fax: (859) 264-2911

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