Ophthalmology Clinical Trials
The Department of Ophthalmology participates in numerous clinical trials involving novel therapeutic and diagnostic methods for various eye diseases, including:
A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of TOUR006 with Treatment Extension in Participants with Thyroid Eye Disease (PI L. Glass)
The purpose of this study is to evaluate the efficacy of SC TOUR006 in reducing signs and symptoms of thyroid eye disease at Week 20. The aims of this study are to evaluate the short- and long-term efficacy and safety of 50 mg of TOUR006, compared with placebo, administered subcutaneously and to characterize the pharmacokinetics, pharmacodynamics, and immunogenicity of TOUR006 in participants with thyroid eye disease.
PI: Lora Glass, MD
Contact: Edylin Bautista, MD email: mmb2225@cumc.columbia.edu
Sponsor: Tourmaline Bio, Inc
ClinicalTrials.gov: NCT06088979(link is external and opens in a new window)
ASCENT: A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of ABBV-RGX-314 Gene Therapy in Participants with Neovascular AMD (Wet AMD) (PI: T. Tezel)
This is a phase 3, multicenter, partially masked, randomized, active-controlled, parallel arm study in participants with nAMD to investigate the efficacy and safety of two doses of RGX-314 administered as a single subretinal injection in the study eye. Participants in the control arm will receive aflibercept administered intravitreally in the study eye over 54 weeks.
PI: Tongalp Tezel, MD
Contact: Maribel Rodriguez, MD mr3208@cumc.columbia.edu
Sponsor: REGENXBIO Inc.
ClinicalTrials.gov: NCT05407636(link is external and opens in a new window)
ASCENT FOLLOW-UP: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degenerationand Fellow Eye Treatment Substudy (PI: T. Tezel)
This is a prospective, observational study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in one of the parent clinical studies (eg, RGX-314-001, RGX-314-2103, RGX-314-2104 [also known as M23-416] and RGX-314-3101 [also known as M23-409]) for the treatment of nAMD in which they received a single subretinal administration of ABBV-RGX-314 in their study eye.
PI: Tongalp Tezel, MD
Contact: Maribel Rodriguez, MD mr3208@cumc.columbia.edu
Sponsor: ABBVIE, Inc.
ClinicalTrials.gov: NCT06088979(link is external and opens in a new window)
Nicotinamide (Vitamin B3) and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study (PI: A. Shukla)
The Columbia Ophthalmology Glaucoma Division and Clinical Trials Unit is conducting a clinical research study to test if nutritional supplements are a safe and effective therapy for preventing worsening of visual field loss related to glaucoma and for restoring visual function in glaucoma. The supplements, nicotinamide (vitamin B3) and pyruvate, have been used for conditions such as dementia, diabetes, and high blood pressure. In a pilot study (De Moraes CG et al. JAMA Ophthalmology. 2022 Jan 1;140(1):11-18, https://pubmed.ncbi.nlm.nih.gov/34792559/(link is external and opens in a new window)) at Columbia Ophthalmology, patients on these supplements experienced visual field improvement as compared to those on placebo.
Participants in this randomized clinical trial will receive either a combination of nicotinamide and pyruvate or placebo for a period of 20 months. This study consists of in-person visits to the NYC offices (880 3rd Avenue or 622 West 168th Street) and periodic phone calls for the purposes of the study and for usual glaucoma care. Participants will receive the study supplements and study-related tests and exams at no cost.
You may be eligible for the study if you meet the following criteria:
- Are between 35-85 years of age
- Are diagnosed with open-angle glaucoma
- Are willing to take that study supplements for a period of 20 months
PI: Aakriti Shukla, MD
Contact: Ioannis Michalopoulos im2482@cumc.columbia.edu(link sends e-mail)
Sponsor: Brown Family Fund, The Glaucoma Foundation
ClinicalTrials.gov: NCT05695027(link is external and opens in a new window)
CAPRICORN Study: Comprehensive Analysis of Pathogens, Resistomes, and Inflammatory-markers in the Cornea
The purpose of this study is to assess worldwide surveillance of organisms responsible for infectious keratitis, antimicrobial resistance (AMR) in corneal ulcer pathogens and to define host immune response transcriptional profiles in keratitis.
PI: Lee Jee Suh, MD
Contact: Edylin Bautista, MD email: mmb2225@cumc.columbia.edu
Sponsor: University of California, San Franscico and the National Eye Institute.
ClinicalTrials.gov:
ORACLE: A Long-Term Follow-Up Study to Evaluate the Safety and Durability of Gt005 in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration Treated in a Gyroscope-Sponsored Antecedent Study (PI: T. Tezel)
This is a prospective, multi-centre, long-term, follow-up study for participants who received GT005 in an antecedent clinical study (GT005-02 or GT005-03).The purpose of this study is to evaluate the long-term safety of GT005, the long-term durability of GT005 on geographic atrophy progression, and the long-term durability of GT005 on functional measures.
PI: Tongalp Tezel, MD
Contact: Maribel Rodriguez, MD mr3208@cumc.columbia.edu
Sponsor: Gyroscope Therapeutics, UK
ClinicalTrials.gov: NCT05481827(link is external and opens in a new window)
Pigmentary Glaucoma – Determining Genetic Causality of Pigmentary Glaucoma (PI: R. Allikments)
Pigmentary glaucoma, a type of open angle glaucoma, typically affects young, near-sighted individuals. Although current research suggests that pigmentary glaucoma runs in families, little is known about genetic basis of the condition. This study seeks to better understand how genetic variation contributes to an individual’s chance to develop pigmentary glaucoma and the likelihood of disease progression after diagnosis. Expanding our understanding of the genetic basis of pigmentary glaucoma may allow for more refined methods of diagnosis as well as targeted treatment options for this condition.
PI: Rando Allikmets, PhD
Contact: Marzhan Atakulova, MD ma3448@cumc.columbia.edu (link sends e-mail)
Sponsor: Brown Family Fund
Basic Human Research Study of Novel Glaucoma Endpoints and Identification of Optimal Patient Populations for Neuroprotection Trials (MAPS) (PI: J. Liebmann)
To obtain longitudinal structural and functional measurements in glaucoma patients to identify novel and optimal endpoints for measuring disease progression in neuroprotection. To identify glaucoma patient sub-populations who may be at risk for rapid disease progression, and to identify risk factors for rapid disease progression.
PI: Jeffrey Liebmann, MD
Contact: Ioannis Michalopoulos im2482@cumc.columbia.edu(link sends e-mail)
Sponsor: Novartis International AG(link is external and opens in a new window)
Publication (Click here): (link is external and opens in a new window)