E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma and Glaucoma suspect |
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E.1.1.1 | Medical condition in easily understood language |
Normal or elevated eye pressure which can cause optic(eye)nerve damage resulting in reduced field of vision |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006028 |
E.1.2 | Term | Borderline glaucoma (glaucoma suspect) |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | Glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Does oral acetazolamide (Diamox) significantly reduce intraocular pressure in patients with glaucoma, who are receiving Lucentis injections for wet Age-related Macular Degeneration. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
TO minutes, T5 minutes, T10 minutes and finally T30 minutes. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial will be the completion of the last patient.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |