Condition category
Eye Diseases
Date applied
11/10/2006
Date assigned
04/12/2006
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Garway-Heath

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06-Q0406-27

Study information

Scientific title

The United Kingdom Glaucoma Treatment Study

Acronym

UKGTS

Study hypothesis

The proposed study is a randomised, double-masked, placebo-controlled treatment study to demonstrate the effectiveness of latanoprost in reducing the frequency of progression events compared to placebo-treated eyes (primary outcome).

The main secondary outcomes of the study are the identification of risk factors for progressive glaucoma and an evaluation of measurements of the rate of progression of glaucoma by measurement of optic nerve head (ONH) and retinal nerve fibre layer (RNFL) structure with quantitative imaging technology, and of visual function with conventional perimetry. It is anticipated that the use of rates of progression will enable improved study designs for subsequent clinical trials.

Ethics approval

Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee, 01/06/2006, REC ref: 06/Q0406/27

Study design

Randomised double-masked placebo-controlled treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Glaucoma

Intervention

Eligible patients will be randomised to one of two treatment arms:
1. Latanoprost for 18 months
2. Placebo for 18 months

It is anticipated that enrolment will take one year, giving a total study duration of 30 months.
Patients reaching a safety endpoint will cross over into the treated arm and continue to be followed. A data monitoring committee will be set up to review study safety and progress.

Intervention type

Drug

Phase

Not Applicable

Drug names

Latanoprost

Primary outcome measures

The effectiveness of Latanoprost in reducing the frequency of progression events compared to placebo-treated eyes.

Secondary outcome measures

1. The identification of risk factors for progressive glaucoma
2. An evaluation of measurements of the rate of progression of glaucoma by measurement of ONH and RNFL structure with quantitative imaging technology, and of visual function with conventional perimetry.

It is anticipated that the use of rates of progression will enable improved study designs for subsequent clinical trials.

Overall trial start date

01/11/2006

Overall trial end date

31/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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 more than or equal to 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 two consecutive reliable post-screening VFs) of two or more contiguous points with P less than 0.01 loss or greater, or three or more contiguous points with P less than 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. Note: this differs from the Early Manifest Glaucoma Treatment (EMGT) criteria - Glaucoma Hemifield Test (GHT) outside normal limits in the same sector on two consecutive tests performed on different days, or GHT Borderline in the same sector on two consecutive tests performed on different days and obvious localised glaucomatous changes of the optic disc in an area corresponding to the field defect
2. Intraocular pressure: mean (screening and training visit) less than 30 mmHg, any intraocular pressure (IOP) less than 35 mmHg
3. Age: adult over 18 years (note: this differs from EMGT where the age range was 50 to 80 years of age)
4. Snellen visual acuity equal to or better than 6/12
5. Able to give informed consent and attend at the required frequency for the duration of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

686 in total

Participant exclusion criteria

1. 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 less than 10 dB) in either eye (note: EMGT had no extra criteria for paracentral points)
2. Intraocular pressure more than 35 mmHg on two consecutive occasions in either eye
3. Unable to perform reliable visual field testing (less than 15% false positives, less than 20% fixation losses)
4. Unable to provide sufficient quality Heidelberg Retina Tomograph (HRT) images (mean pixel height standard deviation [MPHSD] less than 40 µm)
5. Cataractous lens gradings of more than N1, C2, or P1 according to Lens Opacities Classification System III (LOCS III)
6. Previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation)
7. Cataract extraction with posterior chamber lens implantation within the last year
8. Diabetic retinopathy

Recruitment start date

01/11/2006

Recruitment end date

31/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust (UK)

Sponsor details

162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Government

Website

http://www.moorfields.nhs.uk/Home

Funders

Funder type

Industry

Funder name

Pfizer Pharmaceuticals (UK) - unresticted grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22986112
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24126032
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25533656
4. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26393667

Publication citations

  1. Protocol

    Garway-Heath DF, Lascaratos G, Bunce C, Crabb DP, Russell RA, Shah A, , The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, placebo-controlled clinical trial: design and methodology., Ophthalmology, 2013, 120, 1, 68-76, doi: 10.1016/j.ophtha.2012.07.028.

  2. Results

    Lascaratos G, Garway-Heath DF, Burton R, Bunce C, Xing W, Crabb DP, Russell RA, Shah A, , The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, double-masked, placebo-controlled trial: baseline characteristics., Ophthalmology, 2013, 120, 12, 2540-2545, doi: 10.1016/j.ophtha.2013.07.054.

  3. Results

    Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG, Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial, Lancet, 2014, doi: 10.1016/S0140-6736(14)62111-5.

  4. Results

    Zhu H, Crabb DP, Ho T, Garway-Heath DF, More Accurate Modeling of Visual Field Progression in Glaucoma: ANSWERS, Invest Ophthalmol Vis Sci, 2015 , 56, 10, 6077-6083, doi: 10.1167/iovs.15-16957.

Additional files

Editorial Notes