Closed Glaucoma Trials


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: Closed (study completed May 2017).

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
Last Updated: 01/23/2018


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: Closed.

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)
Last Update: 01-23-2018


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

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
Last Update: 01-23-2018


A phase 3 prospective, randomized, double masked, 12-week, parallel, group study evaluating the efficacy and safety of latanoprost and timolol in paediatric subjects with glaucoma

PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Closed.

Summary: The purpose of this study is to evaluate the safety of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol (0.5% or optionally 0.25% for subjects younger than 3 years old) dosed twice-daily in pediatric subjects ≤18 years of age who are diagnosed with pediatric glaucoma.

Inclusion criteria:
• Pediatric subjects (up to age 18) who are diagnosed with glaucoma and require medication to lower the eye pressure.
• If taking glaucoma medication, the eye pressure is ≥22 mm hg in at least one eye after the appropriate washout period from glaucoma medications.

Exclusion criteria:
• Require surgery for acute angle closure or closed or a narrowly open anterior
chamber angle
• Have failed previous long-term therapeutic intervention with either timolol or a prostaglandin to control elevated eye pressure

Contact: Donna Leef, MMSc, COMT (404) 778-4134
Sponsor: Pfizer


A multi-center, prospective, investigator-masked, randomized, parallel study to compare the iop lowering efficacy and safety of Combigan® (fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate) with timolol (0.5% timolol maleate), when each is used as adjunctive therapy to Xalatan® (0.005% latanoprost) in subjects with open-angle glaucoma and ocular hypertension.

PI: Anastasios Costarides, M.D., PhD
Coordinator: Donna Leef, MMSC, COMT
Status: Closed.

Summary: The objective of this study is to compare the eye pressure lowering effictiveness and safety of Combigan® (fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate) to timolol (0.5% timolol maleate), when each is used as adjunctive therapy to Xalatan® (0.005% latanoprost) in subjects with glaucoma or ocular hypertension.

Inclusion criteria:
1. Male or female subjects (aged 18 or older);
2. Have either ocular hypertension, open-angle glaucoma, chronic angle-closure glaucoma with patent iridotomy, which requires medical therapy with an anti-glaucoma/ocular hypotensive agent.

Exclusion criteria:
1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
2. Have any corneal abnormality preventing accurate eye pressure measurements.
3. Have a history of active eye inflammation (uveitis)
4. End stage glaucomatous visual field loss
6. History of corneal refractive surgery (LASIK)
7. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception;

Contact: Donna Leef, MMSC, COMT (404) 778-4134
Sponsor: Allergan, Inc.


Ocular Hypertension Treatment Study (OHTS)

PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Enrollment completed 1996, continuing into the 14th year
of data collection with additional visual function testing.

Summary: Now that OHTS has proven that lowering eye pressure
is effective in delaying or preventing glaucoma in individuals with
ocular hypertension, it is important to determine when treatment
should be started. Following the finding in 2002, all OHTS participants
were offered eyedrop medications. By treating all participants
in both groups with eyedrop medications, we should be able to
determine if there is a penalty for waiting to institute treatment.

Inclusion Criteria: N/A

Exclusion Criteria: N/A

Contact: Donna Leef, MMSc, COMT, 404-778-4134
Sponsor: NEI


A Study of the Safety and Efficacy of Anecortave
Acetate for Treatment of Steroid Induced IOP Elevation

PI: Allen Beck, MD
Coordinators: Donna Leef, MMSc, COMT
Status: Closed.

Summary: To evaluate the safety and efficacy of a sub-Tenon’s
injection of Anecortave Acetate in pts with steroid induced glaucoma.

Inclusion Criteria:
• Pts that have received intravitreal steroid therapy
• Pts between 2 and 8 weeks (14 to 56 days) post-intravitreal steroid
therapy, with an IOP of at least 24 mmHg and who have had
an IOP increase ≥ 10 mmHg relative their pre-intravitreal steroid
IOP in a single eye
• Pts using at least 30 days of stable dosing of ocular hypotensive
medications prior to screening

Exclusion Criteria:
• Intravenous or subcutaneous anticoagulant therapy, or patient is
on oral anticoagulant therapy
• History of ocular trauma within the past 6 months in the study
eye
• History of penetrating glaucoma surgery
• History of allergy to the steroid family of drugs
• History of insertion of scleral buckle in the study eye
• C/D ratio greater than 0.80 (horizontal and vertical) in either eye
• Pts with clinical evidence of scleral thinning

Contact: Donna Leef, MMSc, COMT, 404-778-4134,
Sponsor: Alcon


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

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: Closed.

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)


A phase 3 prospective, randomized, double masked, 12-week, parallel, group study evaluating the efficacy and safety of latanoprost and timolol in paediatric subjects with glaucoma

PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Closed.

Summary: The purpose of this study is to evaluate the safety of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol (0.5% or optionally 0.25% for subjects younger than 3 years old) dosed twice-daily in pediatric subjects ≤18 years of age who are diagnosed with pediatric glaucoma.

Inclusion criteria:
• Pediatric subjects (up to age 18) who are diagnosed with glaucoma and require medication to lower the eye pressure.
• If taking glaucoma medication, the eye pressure is ≥22 mm hg in at least one eye after the appropriate washout period from glaucoma medications.

Exclusion criteria:
• Require surgery for acute angle closure or closed or a narrowly open anterior
chamber angle
• Have failed previous long-term therapeutic intervention with either timolol or a prostaglandin to control elevated eye pressure

Contact: Donna Leef, MMSc, COMT (404) 778-4134
Sponsor: Pfizer


A multi-center, prospective, investigator-masked, randomized, parallel study to compare the iop lowering efficacy and safety of Combigan® (fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate) with timolol (0.5% timolol maleate), when each is used as adjunctive therapy to Xalatan® (0.005% latanoprost) in subjects with open-angle glaucoma and ocular hypertension.

PI: Anastasios Costarides, M.D., PhD
Coordinator: Donna Leef, MMSC, COMT
Status: Closed.

Summary: The objective of this study is to compare the eye pressure lowering effictiveness and safety of Combigan® (fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate) to timolol (0.5% timolol maleate), when each is used as adjunctive therapy to Xalatan® (0.005% latanoprost) in subjects with glaucoma or ocular hypertension.

Inclusion criteria:
1. Male or female subjects (aged 18 or older);
2. Have either ocular hypertension, open-angle glaucoma, chronic angle-closure glaucoma with patent iridotomy, which requires medical therapy with an anti-glaucoma/ocular hypotensive agent.

Exclusion criteria:
1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
2. Have any corneal abnormality preventing accurate eye pressure measurements.
3. Have a history of active eye inflammation (uveitis)
4. End stage glaucomatous visual field loss
6. History of corneal refractive surgery (LASIK)
7. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception;

Contact: Donna Leef, MMSC, COMT (404) 778-4134
Sponsor: Allergan, Inc.


Ocular Hypertension Treatment Study (OHTS)

PI: Allen Beck, MD
Coordinator: Donna Leef, MMSc, COMT
Status: Enrollment completed 1996, continuing into the 14th year
of data collection with additional visual function testing.

Summary: Now that OHTS has proven that lowering eye pressure
is effective in delaying or preventing glaucoma in individuals with
ocular hypertension, it is important to determine when treatment
should be started. Following the finding in 2002, all OHTS participants
were offered eyedrop medications. By treating all participants
in both groups with eyedrop medications, we should be able to
determine if there is a penalty for waiting to institute treatment.

Inclusion Criteria: N/A

Exclusion Criteria: N/A

Contact: Donna Leef, MMSc, COMT, 404-778-4134
Sponsor: NEI


A Study of the Safety and Efficacy of Anecortave
Acetate for Treatment of Steroid Induced IOP Elevation

PI: Allen Beck, MD
Coordinators: Donna Leef, MMSc, COMT
Status: Approved and currently enrolling

Summary: To evaluate the safety and efficacy of a sub-Tenon’s
injection of Anecortave Acetate in pts with steroid induced glaucoma.

Inclusion Criteria:
• Pts that have received intravitreal steroid therapy
• Pts between 2 and 8 weeks (14 to 56 days) post-intravitreal steroid
therapy, with an IOP of at least 24 mmHg and who have had
an IOP increase ≥ 10 mmHg relative their pre-intravitreal steroid
IOP in a single eye
• Pts using at least 30 days of stable dosing of ocular hypotensive
medications prior to screening

Exclusion Criteria:
• Intravenous or subcutaneous anticoagulant therapy, or patient is
on oral anticoagulant therapy
• History of ocular trauma within the past 6 months in the study
eye
• History of penetrating glaucoma surgery
• History of allergy to the steroid family of drugs
• History of insertion of scleral buckle in the study eye
• C/D ratio greater than 0.80 (horizontal and vertical) in either eye
• Pts with clinical evidence of scleral thinning

Contact: Donna Leef, MMSc, COMT, 404-778-4134
Sponsor: Alcon

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