Comparing two treatment approaches for wet macular degeneration
A Randomised Controlled Trial Testing the Efficacy of the Treatment Strategy Observe-and-Plan Against Standard Treat-and-Extend in a Population of Newly Referred Patients With Age-related Macular Degeneration.
This study is testing if a new treatment plan called 'Observe and Plan' can help people with wet macular degeneration see as well as the current method while needing fewer injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Molde and 2 other locations) |
| Trial ID | NCT04420923 on ClinicalTrials.gov |
What this trial studies
This study aims to compare a new treatment protocol called 'Observe and Plan' with the current standard 'Treat and Extend' for patients with wet macular degeneration. The research will assess whether the new protocol can achieve similar visual acuity outcomes with fewer treatment controls and injections. It is hypothesized that patients will experience greater satisfaction with the 'Observe and Plan' approach, which may lead to improved healthcare efficiency. This is the first randomized controlled trial to evaluate these treatment strategies directly.
Who should consider this trial
Good fit: Ideal candidates are individuals newly diagnosed with active choroidal neovascularization due to age-related macular degeneration.
Not a fit: Patients with prior treatments for their eye condition or other significant eye diseases affecting visual acuity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and patient-friendly treatment protocol for wet macular degeneration.
How similar studies have performed: While similar treatment strategies have been suggested, this is the first randomized controlled trial to test the 'Observe and Plan' approach, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed age-related macular degeneration according to criteria. * new diagnose of active CNV verified with OCTA or FA / ICGA. * BCVA ≥ 20/200 measured with ETDRS visual acuity chart * written informed consent Exclusion Criteria: * Eyes formerly treated with anti-VEGF, photodynamic therapy, radiation therapy, transpupillary thermotherapy or focal laser photocoagulation involving the macular area. * Geographic atrophy and subretinal fibrosis affecting the patient's visual acuity. * Any other ongoing eye disease that influences patient's visual acuity, such as glaucoma with central vision loss, proliferative diabetic retinopathy, diabetic macular edema or chronic uveitis.
Where this trial is running
Molde and 2 other locations
- Molde Hospital — Molde, Norway (Recruiting)
- Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital — Trondheim, Norway (Recruiting)
- Ålesund Hospital — Ålesund, Norway (Recruiting)
Study contacts
- Principal investigator: Dordi Austeng, MD PhD — Norwegian University of Science and Technology, Fac MH, INB
- Study coordinator: Margrete Sætre Hanssen, MD
- Email: margrete.saetre.hanssen@ntnu.no
- Phone: +47 91871727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.