Observational study on age-related macular degeneration
Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
This study is looking at people over 55 with early signs of age-related macular degeneration to see how different eye images can help predict how the disease will progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 55 Years to 95 Years |
| Sex | All |
| Sponsor | Universidade Nova de Lisboa Academic / other |
| Locations | 1 site (Lisbon) |
| Trial ID | NCT06355830 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals over 55 years old with drusen associated with intermediate age-related macular degeneration (AMD). Participants will undergo various retinal imaging techniques, including Color Fundus photography, Spectral Domain Optical Coherence Tomography, and OCT-Angiography, to identify imaging predictors of disease progression. The study aims to analyze correlations between drusen morphology, outer retinal layers, and vascular findings to better understand the progression of intermediate AMD. The findings could help in developing targeted interventions for patients with AMD.
Who should consider this trial
Good fit: Ideal candidates are individuals over 55 years old with confirmed drusen secondary to intermediate AMD.
Not a fit: Patients with significant refractive errors, previous retinal surgeries, or other retinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting the progression of age-related macular degeneration, potentially enhancing patient management.
How similar studies have performed: Other studies have shown promise in using multimodal imaging to assess AMD progression, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered. * Accept and sign the consent. Exclusion Criteria: * Patients are excluded if it is not possible to obtain good quality CFP, SD-OCT, OCT-A images, if refractive error is ≥±6D or if there is any evidence of accumulation of extracellular fluid, haemorrhage, exudates or fibrosis. * Additional exclusion criteria included any history of retinal surgery including laser treatment, signs of diabetic retinopathy, history of retinal vascular occlusion, history of anti-VEGF treatment in the study eye or any signs or history of hereditary retinal or macular dystrophy.
Where this trial is running
Lisbon
- Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE — Lisbon, Portugal (Recruiting)
Study contacts
- Principal investigator: Rita Flores, MD — Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
- Study coordinator: Rita Flores, MD
- Email: ritamariaflores@gmail.com
- Phone: 00351218841000
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.