Current Glaucoma Trials

Ocular Hypertension Treatment Study (OHTS)
PI: Allen Beck, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: 20 year follow up of previously enrolled patients

General Summary: The Ocular Hypertension Treatment Study (OHTS), 1992-2012, was a randomized controlled multi-center clinical trial conducted in 22 clinical centers in the United States funded by the National Eye Institute of the National Institutes of Health (EY09307). OHTS was designed to determine whether lowering intraocular pressure (IOP) in individuals with ocular hypertension delays or prevents the development of primary open angle glaucoma (POAG) and risk factors for the development of POAG.

OHTS was the first trial to demonstrate definitively that treatment of elevated intraocular pressure (IOP) delays or prevents the onset of glaucomatous damage. OHTS also identified risk factors for developing primary open-angle glaucoma (POAG) including older age, higher IOP and larger cup/disc ratio, and was the first study to identify central corneal thickness (CCT) as an independent risk factor for the development of POAG.

We will re-examine participants in the Ocular Hypertension Treatment Study (OHTS) after 20 years or more of follow-up to determine the incidence and severity of primary open angle glaucoma (POAG) in the cohort and determine the frequency and severity of self-reported functional limitations associated with POAG. We will also develop a 20-year prediction model for stratifying ocular hypertensive patients by their risk of developing POAG and, among those who developed POAG, a prediction model for the rate of visual field loss.

Clinical Summary: The major goals of this 3rd phase of the study is to re-examine participants in the Ocular Hypertension Treatment Study (OHTS) after 20 years or more of follow-up to determine the incidence and severity of primary open angle glaucoma (POAG) in the cohort and determine the frequency and severity of self-reported functional limitations associated with POAG. Develop a 20-year prediction model for stratifying ocular hypertensive patients by their risk of developing POAG and, among those who developed POAG, a prediction model for the rate of visual field loss.

Inclusion Criteria:
Previously enrolled participant in the Ocular Hypertension Treatment Study (OHTS)

Exclusion Criteria:
Never part of the Ocular Hypertension Treatment Study (OHTS)

Contact: Donna Leef, MMSc, COMT (404) 778-4134, dleef@emory.edu
Posted: 10/31/2016

 

APOLLO - A Randomized (Stage 2) 24-Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Recruitment closed, follow- up phase

General Summary:
The purpose of this study is to investigate the safety and efficacy of Bimatoprost Preservative Free Intracameral Drug Delivery System (Bimatoprost PF IC DDS) in the treatment of open angle glaucoma and ocular hypertension.

Clinical Summary:
As of April, 2014, Bimatoprost SR has shown an acceptable safety profile with single and repeat administrations in ongoing study 192024-041D. In the ongoing 192024-041D phase 1/2 clinical study, preliminary results suggest that Bimatoprost SR is safe and provides similar effectiveness to topical prostaglandin analogs.

Inclusion Criteria:
Some of the inclusion criteria include:
• Male or female, ≥ 18 years of age
• Diagnosis of either open-angle glaucoma or ocular hypertension in both eyes that require IOP-lowering treatment
• Patient is willing to withhold his/her IOP-lowering treatments according to the study requirements, and in the opinion of the investigator can do so without significant risk
• After study testing and measurements at the screening visit, study eligibility requirements are met

Exclusion Criteria:
Some of the exclusion criteria include:
• The need for multiple glaucoma medications to control the eye pressure
• Uncontrolled systemic disease
• Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study
• Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
• Patients who plan for an extended absence away from the area of the study center that would preclude them from returning for all protocol-specified study visits
• Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1) in the study eye

Contact: Donna Leef, MMSc, COMT, (404) 778-4134, dleef@emory.edu
Posted: 05/13/2015

 

ARTEMIS - The Efficacy and Safety of Bimatoprost SR in Patients with Open-angle Glaucoma or Ocular Hypertension
PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Actively recruiting

General Summary:
The purpose of this study is to investigate the safety and effectiveness of two different dose strengths (10 μg or 15 μg) of the Bimatoprost Sustained Release (SR) compared to treatment with Timolol 0.5% eye drops in lowering eye pressure in patients with glaucoma or high eye-pressure. The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug.

Clinical Summary:
Bimatoprost SR is currently being studied in a separate ongoing clinical study in similar subjects with glaucoma or high eye pressure.

As of April, 2014, Bimatoprost SR has shown an acceptable safety profile with single and repeat administrations in ongoing study 192024-041D. In the ongoing 192024-041D phase 1/2 clinical study, preliminary results suggest that Bimatoprost SR is safe and provides similar effectiveness to topical prostaglandin analogs in the dose strengths proposed for this phase 3 investigation.

Inclusion Criteria:
Some of the inclusion criteria include:
• Male or female, ≥ 18 years of age
• Diagnosis of either open-angle glaucoma or ocular hypertension in both eyes that require IOP-lowering treatment
• Patient is willing to withhold his/her IOP-lowering treatments according to the study requirements, and in the opinion of the investigator can do so without significant risk
• After study testing and measurements at the screening visit, study eligibility requirements are met

Exclusion Criteria:
Some of the exclusion criteria include:
• The need for multiple glaucoma medications to control the pressure in the eye
• Uncontrolled systemic disease
• Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study
• Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
• Patients who plan for an extended absence away from the area of the study center that would preclude them from returning for all protocol-specified study visits
• Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1) in the study eye

Contact: Donna Leef, MMSc, COMT, (404) 778-4134, dleef@emory.edu
Posted: 05/13/2015

 

Glaucoma Screening Program
PI: Maria Aaron, MD
Co-Investigators: Susan A. Primo, OD and Kenneth Rosengren, OD
Coordinator: None
Status: Enrolling

Summary: Community glaucoma screening program in conjunction with Emory medical students

Inclusion Criteria:
• Non-profit agency, church or community centers

Exclusion Criteria:
• For-profit businesses

Contact: Susan A. Primo, OD, 404-778-3317
Sponsor: Friends of the Congressional Glaucoma Caucus

 

Tailored Telephone Glaucoma Compliance Study
PI: Karen Glanz, PhD (Rollins School of Public Health)
Co-Investigators: Susan A. Primo, OD, MPH and Allen Beck, MD
Coordinator: Lucja Bundy
Status: Enrolling

Summary: Research aim is to study compliance in glaucoma patients and to test with a new, innovative, health communication strategy.

Inclusion Criteria:
• Glaucoma or glaucoma suspect on eye drops
• Patient at Grady or the VA Hospital

Exclusion Criteria:
• Legal blindness
• Eye surgery within 1 year of the study

Contact:  Lucja Bundy, 404-727-5527
Sponsor: National Eye Institute (R01)

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