E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary open-angle Glaucoma Pseudoexfoliation Glaucoma |
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E.1.1.1 | Medical condition in easily understood language |
Primary open-angle Glaucoma Pseudoexfoliation Glaucoma |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037118 |
E.1.2 | Term | Pseudoexfoliation glaucoma |
E.1.2 | System Organ Class | 100000004853 |
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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 |
Primary study objectives 1) To evaluate the therapeutic benefit of IOP reduction with Latanoprost on the frequency of VF progression events in glaucoma (Hypothesis: Latanoprost reduces the incidence of VF progression events within 18 months by 50%) |
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E.2.2 | Secondary objectives of the trial |
2) To establish the feasibility of initial observation of patients to identify actual progression rates prior to making treatment decisions 3) To identify and quantify the risk factors for progression 4) To establish treatment protocols based on risk profiling and measurement of identifiable rates of progression 5) To conduct a health economic evaluation of the treatment protocols derived from the study data 6) To validate and further refine trial design based on the measurement of rates of structural and functional progression with quantitative imaging and VF testing 7) To identify and quantify the risk factors for response to treatment 8) To establish the relation of structural and functional measurement in progressing patients 9) To obtain pilot data to compare different forms of quantitative imaging device 10) To compare quantitative imaging devices with the reference standard of optic disc photography |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria a) Newly detected, previously untreated open-angle glaucoma (including primary open-angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye. Glaucoma is defined as: reproducible glaucomatous visual field (VF) defects in at least one eye with corresponding damage to the optic nerve head (cup disc ratio > or = 0.7 and/or focal narrowing of the neural rim) and in the absence of retinal or neurological condition that may account for the VF loss. A glaucomatous VF is defined as a reproducible defect (in at least 2 consecutive reliable post-screening VFs) of two or more contiguous points with P < 0.01 loss or greater, or three or more contiguous points with P < 0.05 loss or greater, or a 10-dB difference across the nasal horizontal midline at two or more adjacent points in the total deviation plot.36 b) Intraocular pressure: mean (screening and training visit) less than 30mmHg, any IOP <35mmHg c) Age: adult (over 16 years – UK Clinical Trials Regulations 2004) Note: this differs from EMGT where the age range was 50 to 80 years of age d) Snellen visual acuity better than 6/12 e) Able to give informed consent and attend at the required frequency for the duration of the study |
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E.4 | Principal exclusion criteria |
Exclusion criteria a) Moderately advanced visual field loss (mean deviation worse than -10dB in the better eye or worse than -16 dB in the other eye) or a threat to fixation (paracentral point total sensitivity < 10dB) in either eye Note: EMGT had no extra criteria for paracentral points b) Intraocular pressure > 35mmHg on two consecutive occasions in either eye c) Unable to perform reliable visual field testing (<15% false positives, <25% false negatives, <25% fixation losses) d) Unable to provide sufficient quality HRT images (MPHSD <35m) e) Cataractous lens gradings of more than N1, C2, or P1 according to LOCS II f) Previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation) g) Cataract extraction with posterior chamber lens implantation within the last year h) Diabetic retinopathy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Outcomes: The primary outcomes are: 1. Visual field progression within 18 months as defined in the EMGT study – at least 3 test points showing significant progression (on the pattern deviation Glaucoma Change Probability Maps), as compared with baseline, at the same locations on three consecutive occasions |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | Yes |
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 | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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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Study endpoints: 1. IOP > 35mmHg on two successive occasions 2. Visual field progression as defined in the EMGT study. An independent ophthalmologist will confirm whether VF loss is consistent with glaucoma or a non-glaucomatous process (such as vein occlusion, stroke, or age-related macular degeneration). 3. decline of best-corrected visual acuity to below 6/18 |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |