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Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma
EU CTIS ID: 2023-510041-16-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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)].
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.