2023-510041-16-00Active, not recruitingPhase 4
Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 6 May 2024
- Start date
- 22 Apr 2013
- Lead sponsor
- Region Vaesterbotten
- Diseases
- Glaucoma
- EU CT number
- 2023-510041-16-00
- EudraCT number
- 2013-002895-42
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 240
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intraocular surgery except uncomplicated cataract operation.
Other illness
- Disease or condition that probably prohibits long-term follow-up.
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Vaesterbotten | Umea | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.