Ophthalmology Clinical Trials

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

Recruitment status: Active
Enrollment: Open

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

Recruitment status: Completed
Enrollment: Closed​​​​

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

Recruitment status: Completed
Enrollment: Closed

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/) 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.

PI: Aakriti Shukla, MD
Contact: Ioannis Michalopoulos  im2482@cumc.columbia.edu 
Sponsor: Brown Family Fund, The Glaucoma Foundation

ClinicalTrials.gov: NCT05695027

Recruitment status: Completed
Enrollment: Closed

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.

Recruitment status: Active
Enrollment: Open

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: Novartis Pharmaceuticals Corporation

ClinicalTrials.gov: NCT05481827

Recruitment status: Completed
Enrollment: Closed

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 
Sponsor: Brown Family Fund

Recruitment status: Active
Enrollment: Open

Retinoblastoma is the most common pediatric malignant intraocular tumor and originates from the retina. Treatment of eyes with advanced intraocular retinoblastoma remains a challenge. The historic standard of care for patients with unilateral disease is enucleation and for those with bilateral disease, a variety of modalities have been tried. These include radiation therapy, systemic chemotherapy, periocular administration of chemotherapy, selective intra-arterial chemotherapy, and intravitreal chemotherapy. Unfortunately, all of these modalities are associated with significant morbidity and investigators are looking for new ways to treat these patients either with novel directed drug delivery methods or with new less toxic agents. This study will evaluate the safety and efficacy of topotecan delivered directly to the eye using a novel sustained-release topotecan episcleral delivery system (also referred to as a Chemoplaque) in patients with active de novo or recurrent intraocular retinoblastoma in at least one eye following completion of first-line therapy. The study intervention involves the insertion and removal of the Chemoplaque, examinations under anaesthesia (EUAs), visits to clinic to monitor for adverse events throughout, and post plaque removal toxicity evaluation. EUAs, clinic visits and laboratory tests are standard of care for retinoblastoma patients. 

PI: Brian Marr, MD
Contact: Patricia Lemberg, MD email: pl2853@cumc.columbia.edu
Sponsor: Targeted Therapy Technologies, LLC.

ClinicalTrials.gov: NCT04156347

Recruitment status: Active
Enrollment: Open

The study is a prospective observational study of patients with STGD1, the aim of which is to further enhance understanding of disease progression and structural and functional markers that can be used to evaluate the efficacy and safety of therapeutic interventions, especially in light of advancements in imaging technology.

PI: Vlad Diaconita, MD
Contact: Maribel Rodriguez, MD   mr3208@cumc.columbia.edu 
Sponsor: SpliceBio, SL.

ClinicalTrials.gov: NCT06435000

Recruitment status: Active
Enrollment: Open

Accordion content...First-in-human trials are conducted primarily to determine the safe dose range for further clinical development of promising drug candidates. This first-in-human study is being conducted to identify doses of SB-007 that are safe and demonstrate a potential efficacy signal in subjects with moderate or advanced STGD1.

PI: Vlad Diaconita, MD
Contact: Maribel Rodriguez, MD   mr3208@cumc.columbia.edu 
Sponsor: SpliceBio, SL.

ClinicalTrials.gov: NCT06942572

Recruitment status: Active
Enrollment: Open

AccordionThis prospective observational, low-interventional, non-drug study aims to further characterize anatomical and functional biomarkers in DR. The study will enable observation of routine treatments or assessments for DR. Some of these assessments are performed as part of the standard of care. There will be additional assessments outside of routine and therefore the study is classified as low-interventional.

PI: Vlad Diaconita, MD
Contact: Maribel Rodriguez, MD   mr3208@cumc.columbia.edu 
Sponsor: Roche, Inc.

Recruitment status: Active
Enrollment: Open