Current Glaucoma Trials

ATHENA- A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
PI: Anastasios Costarides, M.D., PhD.
Coordinator: Donna Leef, MMSc., COMT
Status: Enrollment beginning February 2018

General Summary:
The purpose of this study is to investigate the safety and effectiveness of an experimental drug called Bimatoprost SR (sustained release) compared with selective laser trabeculoplasty (SLT) for glaucoma or high eye pressure. Approximately 160 subjects will participate in this study nationwide. At Emory, we will enroll 12.

Clinical Summary:
Bimatoprost SR is currently being studied in a separate ongoing clinical studies in similar subjects with glaucoma or high eye pressure. At Emory. We have participated in 2 of these studies. As of April, 2014, Bimatoprost SR has shown an acceptable safety profile with single and repeat administrations in ongoing study 192024-041D.

SLT is a form of laser eye surgery that is used to lower eye pressure in subjects with glaucoma or high eye pressure. During the procedure laser energy is applied to the drainage tissue in the eye. This starts a biological change in the tissue that results in better drainage of fluid, lowering eye pressure. The Bimatoprost SR is an experimental implant that is very small, is biodegradable (dissolves naturally in the body), and contains a 15 µg dose of the bimatoprost drug. Bimatoprost SR is placed inside the eye in the intracameral area (between the cornea [the clear part of the eye] and the iris [the colored part of the eye]).

In this study, you will be randomly assigned (like the flipping of a coin) to receive either SLT or Bimatoprost SR in one eye. You have an equal chance to receive either SLT or Bimatoprost SR in this eye. The other eye will receive the alternate study drug or procedure. To prevent bias, the study doctor will also perform “sham” or pretend procedures on your eyes, so you will not know which eye which received which SLT or Bimatroprost SR.

Inclusion Criteria:
Some of the inclusion criteria include:
• Male or female, ≥ 18 years of age
• give written informed consent and authorization for use and release of personal health information
• have a level of eye pressure that in your doctor’s opinion, is not adequately managed with topical medication for reasons other than the medication being effective (e.g., due to side effects or not remembering to use your drops)
• have a level of eye pressure that in your investigator’s opinion, can be treated adequately with topical medication in the same family as Bimatoprost as sole therapy if taken as directed
• are a suitable candidate for the SLT procedure and your investigator feels the SLT procedure can manage your eye pressure
• Have vision better than or equal to 20/50 in each eye
• have open angle glaucoma or ocular hypertension (high eye pressure) in both eyes that requires eye-pressure lowering medicine
• have specific eye and vision measurements that meet the study requirements
• have eye pressure that meets the study requirements
• be willing to stop your eye-pressure lowering medication(s) as instructed by the study doctor
• have a negative pregnancy test if you are a female of child bearing potential

Exclusion Criteria:
• have an uncontrolled disease of the body (this will be determined by your study doctor)
• are a woman who is pregnant, nursing, or planning a pregnancy, or a woman who is of childbearing potential and not using a reliable means of contraception
• have had previous laser treatment for the pressure in your eyes
• have damage to, or undergone certain types of surgery to either eye (this will be determined by your study doctor)
• have had a previous glaucoma laser procedure
• will need surgery in either eye during your participation in the study
• will need certain prohibited eye and/or oral medications during your participation in the study (this will be determined by your study doctor)
• know of any reason why you would not be able to complete the required study visits during your study participation
• have known allergy to any drugs used in this research study.

Contact: Donna Leef, MMSc, COMT; (404) 778-4134; dleef@emory.edu
Date Posted: 01-23-2018


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


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

 

 

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