Treatment of glaucoma (eye disease) - Prospective study where the effect of intensive treatment with eye drops and laser is compared to conventional stepwise increase of treatment.

Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma (GITS Main Study and Extension). - GITS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002895-42-SE

Enrollment

240

Registered

2013-08-07

Start date

2013-10-10

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, open-angle and PEX glaucoma. MedDRA version: 20.0 Level: LLT Classification code 10030856 Term: Open-angle glaucoma System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10037118 Term: Pseudoexfoliation glaucoma System Organ Class: 100000004853

Interventions

Pharmaceutical Form: Eye drops Pharmaceutical Form: Eye drops Pharmaceutical Form: Eye drops Pharmaceutical Form: Eye drops Pharmaceutical Form: Eye drops Pharmaceutical Form: Eye drops Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed open-angle glaucoma (incl. normal pressure glaucoma) or PEX glaucoma in one or both eyes (both eyes can be included as study eyes if they fulfill the criteria of inclusion/exclusion). VFI (Visual Field Index)=65%, applicable for both eyes even if only one eye will be included. Patient should be previously untreated with intraocular pressure lowering medication. Age: 40-78 years at time of inclusion. Additional inclusion criteria for GITS extension • Completed the GITS Main study in Umeå Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Pregnant or breast feeding women or women in childbearing potential not using acceptable contraceptive method. Patients with contraindications to the glaucoma medicine to be given. If there is any obstacle for performing the LTP. Disease or condition that probably prohibits long-term follow-up. Intraocular surgery except uncomplicated cataract operation. Diabetes with proliferative retionopathy or serious non-proliferative retionopathy [(intra-retinal bleedings, pronounced intra-retinal microvasculation, ”definite venous beading” macular edema with hard exudates that reach fovea according to International Clinical Diabetic Retionopathy and Macular Edema Disease Severity scales (Wilkinson et al 2003)]. Neurological and other non-glaucoma conditions, except cataract, that can affect the vision.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the perimetric rate of progression with two types of initial treatment; mono drop therapy and combo drop therapy + third medication + LTP 360° on patients with newly diagnosed open-angle glaucoma, definied as confirmed vision loss with papill/nerve fibre damage.;Secondary Objective: To monitor the effect of adherence for rate of progression. To identify factors at early diagnosis that can effect the rate of progression: Single subject – age, heredity, sex, origin, other diseases, medication, blood pressure. Life style– smoking, BMI, alcohol use, coffee drinking, diet, physical activity Eyes– eye pressure, PEX , refraction, corneal thickness measured with Scheimflug-kamera (Pentacam, Oculus), OCT-techniques (spectral domain optical coherence tomography with enhanced depth imaging). To measure correlation between structure and function during disease progression by examining the nerve fibre layer and ganglion cell layer with spectral domain optical coherence tomography (SD-OCT). Standard Automated Perimetry (SAP) with Humphrey Field Analyser (Carl Zeiss Meditec). To measure Quality of Lite for randomised patients at one month visit and after 3, 5, 8 and 10 years; QoL in relation to treatment alternative and rate of progression. ;Primary end point(s): There are no formal end points. The aim of the study is to compare and follow-up the patients on traditional clinical treatment with those receiving more intensive treatment, and measure the rate of progression as long as possible. ;Timepoint(s) of evaluation of this end point: Not applicable.	—

Measure

Time frame

Main Objective: To compare the perimetric rate of progression with two types of initial treatment; mono drop therapy and combo drop therapy + third medication + LTP 360° on patients with newly diagnosed open-angle glaucoma, definied as confirmed vision loss with papill/nerve fibre damage.;Secondary Objective: To monitor the effect of adherence for rate of progression. To identify factors at early diagnosis that can effect the rate of progression: Single subject – age, heredity, sex, origin, other diseases, medication, blood pressure. Life style– smoking, BMI, alcohol use, coffee drinking, diet, physical activity Eyes– eye pressure, PEX , refraction, corneal thickness measured with Scheimflug-kamera (Pentacam, Oculus), OCT-techniques (spectral domain optical coherence tomography with enhanced depth imaging). To measure correlation between structure and function during disease progression by examining the nerve fibre layer and ganglion cell layer with spectral domain optical coherence tomography (SD-OCT). Standard Automated Perimetry (SAP) with Humphrey Field Analyser (Carl Zeiss Meditec). To measure Quality of Lite for randomised patients at one month visit and after 3, 5, 8 and 10 years; QoL in relation to treatment alternative and rate of progression. ;Primary end point(s): There are no formal end points. The aim of the study is to compare and follow-up the patients on traditional clinical treatment with those receiving more intensive treatment, and measure the rate of progression as long as possible. ;Timepoint(s) of evaluation of this end point: Not applicable.

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Secondary

Measure	Time frame
Secondary end point(s): No secondary end point(s).;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Sweden

Contacts

Public ContactGauti Jóhannesson

Region Västerbotten

gauti.johannesson@umu.se46702200798

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026