“A Randomized, Double Masked, Active Controlled Phase III study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in subjects with Neovascular AMD (VEGF-OD-0605 / VIEW 1 Study)
Primary Investigator: Stanley Chang, M.D.
Sponsor: REGENERON
Status: Enrollment ongoing
Sponsor: The View 1 Study is testing a potential new therapy for age-related macular degeneration (AMD) to assess the efficacy of intravitreal VEGF Trap compared to Lucentis in a non-inferiority paradigm, in preventing moderate vision loss in subjects with all subtypes of neovasclar AMD (for up to 2 years).

“A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion” (FVF4165g / BRAVO Study)
Primary Investigator: Gaetano Barile, M.D.
Sponsor: GENENTECH
Status: Enrollment ongoing
Purpose: This is a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to branch retinal vein occlusion (BRVO).

 “A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion” (FVF4166g / CRUISE Study)
Primary Investigator: Gaetano Barile, M.D.
Sponsor: GENENTECH
Status: Enrollment ongoing
Purpose: This is a Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).

 “Sensitivity of the Home Macular Perimeter (HMP) in the detection of Choroidal Neovascularization(CNV) secondary to Age related Macular Degeneration (AMD)” (HMP V4 Study)
Primary Investigator: Howard Fine, M.D. MHSc
Sponsor: Notal Vision
Status: Enrollment ongoing
Purpose: The V4 Study aims to estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD

“Sensitivity of the Home Macular Perimeter (HMP) in the detection of Choroidal Neovascularization (CNV) secondary to Age related Macular Degeneration (AMD)” (HMP V5 Study)
Primary Investigator:   Howard Fine, M.D., MHSc
Sponsor: Notal Vision
Status: Enrollment will start in Summer 2008.
Purpose: The V5 Study aims to estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD, and differentiate them from intermediate AMD subjects.

“Usability of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients” (HMP UU2 Study)
Primary Investigator: Howard Fine, M.D., MHSc
Sponsor: Notal Vision
Status: Enrollment will start in Summer, 2008
Purpose: The UU2 Study aims to measure the ability of subjects with intermediate AMD to unpack, set the system and pass a tutorial using the Home Macular Perimeter and performing the tests on their own in home simulated environment.

“Triamcinolone for Persisting Macular Edema After Vitrectomy for Macular Pucker”
Primary Investigator: William Schiff, M.D.
Sponsor: Departmental Funding
Status:Enrollment ongoing.
Purpose: To determine if the use of triamcinolone acetonide can improve the visual and anatomic outcomes for patients with persistent retinal thickening 6 weeks after vitrectomy for macular pucker, using two different routes of administration, intravitreal injection and sub-Tenon’s injection.

"A 2 Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson' s Disease Patients" (248.538 / MIRAPEX Safety Study)
Primary Investigator: Gaetano Barile, M.D.
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
Status: Enrollment ongoing.
Purpose: To determine if there is any difference in the presence of retinal deterioration in Parkinson' s Disease patients treated with pramipexole IR versus ropirinole as monitored by an overall review of all components of the comprehensive ophthalmology assessment from the baseline to the end of the study at 2 years.

"A Phase 2 randomized, multicenter, dose-ranging, controlled, parallel-group trial to assess the safety and effectiveness of dexamethasone posterior segment drug delivery system (DEX PS DDS) in the treatment of persistent macular edema" (DC103-06-00 / POSURDEX in ME)
Primary Investigator: Stanley Chang, M.D.
Sponsor: Oculex (Allergan)
Status: Enrollment, treatment, data analysis - completed. Results published.
Purpose: To investigate the safety and effectiveness of Dexamethasone Posterior Drug Delivery System (DEX PS DDS) in the treatment of persistent macular edema (ME).

 "Action to Control Cardiovascular Risk in Diabetes"(ACCORD Study)
 Primary Investigator: William Schiff, M.D.
 Sponsor: NIH/NEI
 Status: Enrollment, baseline evaluation - complete. Patients are in follow-up.
 Purpose: The ACCORD EYE Sub/study is investigating the effects of ACCORD interventions (blood sugar control, blood pressure control and blood lipids control) on the progression of diabetic retinopathy, the leading cause of acquired blindness in adults in the US.

"An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) who have completed the Treatment Phase of a Genentech-Sponsored Ranibizumab Study" (FVF3426g / HORIZON and its Genetic Substudy- DAWN)
Primary Investigator: Gaetano Barile, M.D.
Sponsor:GENENTECH
Status:Enrollment - completed. Study Treatment - ongoing.
Purpose: This extension study is investigating the long-term safety, tolerability and efficacy of multiple intravitreal injections of open-label Lucentis administered to subjects with CNV secondary to AMD who completed the 2 year treatment phase of the MARINA study (at our site).

"A Phase IIIb, Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naïve and Previously Treated Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)" (FVF3689g / SAILOR study)
Primary Investigator: Gaetano Barile, M.D.
Sponsor:GENENTECH
Status: Enrollment, Study procedures completed.
Purpose: The primary objective of this study is to estimate the incidence of ocular and non-ocular serious adverse events in subjects treated with 0.3 mg or 0.5 mg intravitreal Lucentis

"A safety and efficacy assessment of chimeric ribozyme to PCNA to prevent recurrence of proliferative vitreoretinopathy" (IM-VIT 100-01)
Primary Investigator: William Schiff, M.D.
Sponsor: Immusol.
Status: Enrollment, Study Procedures - completed. Results published.
Purpose: To determine the safety and efficacy of VIT100, a PCNA ribozyme, in preventing recurrent proliferative vitreoretinopathy (PVR) in patients with established PVR who undergo vitrectomy for retinal reattachment repair.

“Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) Compared to BSS plus for Use During Surgery for Removal of Epimacular Membrane with Vitrectomy (C-04-18)”
Primary Investigator: Stanley Chang, M.D.
Sponsor: Alcon
Status: Enrollment, Study Procedures completed.
Purpose:To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared   to BSS Plus for use during cataract surgery in patients undergoing Vitrectomy for Epimacular     Membrane.

"A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group Evaluation of the Safety and Efficacy of OT551 Ophthalmic Solution to Prevent Formation or Delay Progression of Nuclear Cataract Formation in Post-Vitrectomy Patients”  (OT-551-002 Study)
Primary Investigator: Stanley Chang, M.D.
Sponsor: OTHERA Pharmaceuticals.
Status: Enrollment, Study Procedures completed. Analysis – ongoing.  
Purpose: To investigate the safety and efficacy of OT551 in the prevention of formation or in delaying the progression of nuclear cataract formation in Post-Vitrectomy patients.

A Study of OncoVEX GM-CSF in Stage IIIc and Stage IV Malignant Melanoma
Primary Investigator: Gaetano Barile, M.D.
Sponsor: BioVex Limited      
Status: Enrollment completed. Patients in follow-up.
Purpose: This study aims to test the ocular safety of OncoVex GM-CSF in treatment of patients with Stage IV Malignant Melanoma.

“Randomized, DB, MC study comparing MDX-010 Monotherapy, MDX-010 in  Combination with a Melanoma Peptide Baccine, and Melanoma Vaccine, & Melanoma Vaccine Monotherapy in HLA-A*0201-Positive Pts w/ Previously treated unresectable stage III or IV Melanoma”
Primary Investigator: Gaetano Barile, M.D.
Sponsor: Medarex
Status: Enrollment, Study Procedures -- completed
Purpose:This study aims to test the ocular safety of MDX-010 in treatment of patients with Stage III or IV Melanoma.

“Glaucoma screening project“
Primary Investigator:  Lama A. Al-Aswad, M.D.
Sponsor: Congressional Glaucoma Caucus
Status: Enrollment ongoing. Patients are being referred to the Baseline Clinic.
Purpose: This community outreach program is trying to identify patients with glaucoma at a very early stage, so  have an opportunity to provide appropriate treatments in a timely manner to prevent the complications.

“Effects of glaucoma surgery (glaucoma tube shunt and filtering surgery) on corneal  endothelium”
Primary Investigator: Lama A. Al-Aswad, M.D.
Sponsor: Departmental Funding
Status: Enrollment ongoing.
Purpose: This study is to evaluate the cornea in patients who have a glaucoma drainage device implanted into their eye.  Specifically, we are investigating the effect, if any, of glaucoma drainage devices on the density of the cells in the corneal endothelium.

“Early Diagnosis of Glaucomatous Optic Neuropathy by Visually Evoked Potentials (VEP) Testing for Rapid Objective Detection of Impairment of Specific Visual Subsystem"
Primary Investigator:   James C. Tsai, M.D.
Sponsor: NIH/SynaBridge.
Status: Enrollment, tests, data analysis - completed. Results – published.
Purpose: To determine how the glaucomatous eye disease affect vision. The information will increase our understanding of eye diseases that affect the retina, the optic nerve and the brain.

 “A Comparison of the Humphrey Topographer and the Pentacam Comprehensive Eye Scanner in detecting Subclinical Keratoconus”
Primary Investigator: Richard Braunstein, M.D.
Sponsor: Departmental Funding
Status:Enrollment ongoing.
Purpose: This study is to investigate the Humphrey Topographer and the Pentacam Comprehensive Eye Scanner in detecting Subclinical Keratoconus in patients being evaluated for refractive eye surgery.

"Epidemiology of Visual Impairment in Clinical Practice"
Primary Investigator: Stanley Chang, M.D.
Sponsor: Departmental Funding
Status: Enrollment ongoing
Purpose: This study attempts to determine how many patients in our practice could benefit from referrals for vision rehabilitation services and to evaluate the value of this service and the effect of this treatment on patients' quality of life.

Bill Kim, Ph.D., Clinical Research Coordinator
Phone: 212.305.5067
Fax: 212.305.9485
Email: billkim@columbia.edu

Joann Kang  (Keratoconus and Fuchs Genetic Study)
Phone: 212.305.5922
Fax: 212.305.9485
Email: jjk2128@columbia.edu