Primary open-angle Glaucoma Pseudoexfoliation Glaucoma MedDRA version: 20.0 Level: LLT Classification code 10037118 Term: Pseudoexfoliation glaucoma System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Latanoprost
Product Name: Xalatan
Product Code: PhXA41
Pharmaceutical Form: Eye drops, solution
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the place
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 324
Exclusion criteria
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 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 <35?m) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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%);Secondary Objective: 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 ;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;Timepoint(s) of evaluation of this end point: 18 Months | — |
Countries
United Kingdom
Contacts
Public ContactSue Lydeard
Moorfields Eye Hospital
Outcome results
None listed