Can Diamox lower the eye pressure in glaucoma or glaucoma suspect patients who are receiving eye injections for wet age related macula degeneration?

• Conditions: Glaucoma and Glaucoma suspect; MedDRA version: 14.1Level: LLTClassification code 10006028Term: Borderline glaucoma (glaucoma suspect)System Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10018304Term: GlaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-023037-35-GB
• Lead Sponsor: York Teaching Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-06
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

The sample group will include glaucoma and glaucoma suspect patients undergoing intravitreal injections for neovascular (wet) AMD at York Hospital.
1.Patients with neovascular (wet) AMD requiring Lucentis injections
2.Glaucoma or Glaucoma suspect
3.Written informed consent
4. Baseline pre injection Intraocular Pressure of less than 30 mmHg

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1.Baseline pre-injection IOP of 30 mmHg or higher
2.Unable to give written informed consent
3.Known allergy to sulphur containing drugs or acetazolamide
4. 18 years or younger
5. Marked kidney or liver disease/dysfunction
6. Supra-renal gland failure
7. Hypercholrcmic adcidosis
8. Hepatic cirrhosis
9. Pregnancy and pre-menopausal women
10. Concomitant use of other oral carbonic anhydrase inhibitors apart from acetazolamide

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does oral acetazolamide (Diamox) significantly reduce intraocular pressure in patients with glaucoma, who are receiving Lucentis injections for wet Age-related Macular Degeneration.;Secondary Objective: n/a;Primary end point(s): Primary endpoint is change in IOP at TO, T5, T10 and finally T30.  A sample size calculation was based on a change of 9mmHg eye pressure in the intervention group versus no change in placebo group.   ;Timepoint(s) of evaluation of this end point: TO minutes, T5 minutes, T10 minutes and finally T30 minutes.