Status:
COMPLETED
Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Glaucoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if one of the genes that can cause glaucoma, called myocilin, are associated with larger eye pressure and blood pressure changes in sitting and lying down pos...
Detailed Description
Glaucoma is an important public health issue, and identifying new markers to improve treatment outcomes is a high priority. Progress in Mendelian genetic approaches has led to identifying 15 genes and...
Eligibility Criteria
Inclusion
- Early OAG, as determined by a comprehensive ophthalmic examination
- Greater than or equal to 18 years of age
- Either gender
- Any race
- Both eyes meet eligibility criteria
- Cup to disc ratio less than 0.8 determined by fundoscopy and confirmed by disc photos
- Visual field parameters in the study eye: Pattern Standard Deviation (PSD) greater than 1.0 dB but less than 6.0 dB
- Ability to cooperate for an outpatient study involving at least five visits over a four month study period
- Ability to comply with Cosopt treatment regimen
Exclusion
- Less than or equal to 18 years old
- Refusal to be genotyped or sign Informed Consent for Protocol 1991-144
- Pregnant or lactating women
- Medical conditions of severe pulmonary compromise with asthma or emphysema or cardiac contraindications to beta-blockers
- Ocular disease of chronic angle-closure glaucoma, iridocorneal endothelial disease, posterior polymorphous corneal dystrophy, epithelial downgrowth, uveitic glaucoma, or neovascular glaucoma
- Ocular surgery for glaucoma, including trabeculectomy, other glaucoma filtration surgery, glaucoma drainage implant, or laser cyclophotocoagulation
- Current use of systemic steroids or chemotherapeutic agents that non-selectively inhibit dividing cells
- Proliferative diabetic retinopathy, history of panretinal photocoagulation treatment, diabetic macular edema, or history of macular grid laser treatment
- History of changing treatment involving the use oral beta-blockers, angiotensin converting enzyme inhibitors, calcium channel blockers, or oral alpha 2-agonists in the prior two months or in the next month (i.e., must be on stable treatment with any of these drugs for at least two months)
- Patients taking erectile dysfunction drugs (i.e., Viagra, Cialis, Levitra)
- Contradictions:
- bronchial asthma or a history of bronchial asthma
- severe chronic obstructive pulmonary disease
- sinus bradycardia
- second or third degree atrioventricular block
- overt cardiac failure
- cardiogenic shock
- hypersensitivity to any component of Cosopt
Key Trial Info
Start Date :
August 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00906087
Start Date
August 4 2009
End Date
July 18 2012
Last Update
June 2 2017
Active Locations (1)
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1
W.K. Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105