Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

Recruiting

• Conditions: age-related Macula degeneration; retina aging; 10047060

• Registration Number: NL-OMON44313
• Lead Sponsor: niversity Hospital Bonn, UKB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

General Inclusion criteria (applicable to all groups)
1. Male and female subjects.
2. Aged 55 - 85 years at baseline.
3. Able and willing to provide written informed consent and to comply with the study protocol visits and assessments.;Intermediate AMD
1. Study eye must have iAMD and,
2. The fellow eye must have iAMD and/or, in addition, extrafoveal GA (no atrophy within the central ETDRS subfield), maximum total GA size is 1.25 mm2.
Definition of iAMD: large drusen >125 µm and/or any AMD pigmentary abnormalities, that are definite hyper- or hypopigmentary abnormalities associated with medium or large drusen but not associated with other known disease entities. (See table 4-1 for more specifications). If both eyes are eligible for the study based on inclusion criteria, the eye with better visual acuity (i.e. on BCVA) will be selected as the study eye as this will improve reliability of functional testing and quality of image acquisition and thus improve sensitivity to detect change over time. In cases in which both eyes have the same visual acuity, the study eye will be selected at random by the investigator.
3. ETDRS letter chart BCVA in the study eye not worse than 72 letters (approximately 20/40 Snellen VA equivalent).
4. All general inclusion criteria.;Late AMD
1. Subjects with bilateral GA, bilateral nAMD or nAMD in one eye and GA in the other (See table 4-1 for more specifications).
2. BCVA between 20/80 and 20/200 in study eye.
3. All general inclusion criteria.;Early AMD
1. Subjects with medium drusen > 63µm and <= 125µm and no AMD pigmentary abnormalities in both eyes and not signs of intermediate or late AMD. (See table 4-1 for more specifications).
2. All general inclusion criteria. ;No AMD
1. No signs of early, intermediate or late AMD in both eyes. (See table 4-1 for more specifications).
2. All general inclusion criteria only.

Exclusion Criteria

General Exclusion criteria (applicable to all groups)
1. Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator.
2. Severe ptosis, extraocular motility restriction or head tremor preventing adequate fundus visualization in the opinion of the investigator.
3. Any signs of nAMD or GA according to the criteria descried in table 4-1 (does not apply to the late AMD group).
4. Any concurrent intraocular condition in the study eye (e. g. glaucoma or cataract) that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
5. Severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
6. Any diabetic macular edema or macular disease
7. Ocular disorders in the study eye (i. e., pre-retinal membrane) at the time of enrolment that may confound interpretation of study results and compromise visual acuity.
8. Diagnosis of uncontrolled glaucoma with intraocular pressure of >30 mmHg (despite current pharmacological or non-pharmacological treatment).
9. Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study.
10. Concomitant treatment for AMD in either eye (concomitant use of vitamins/supplements is not excluded; does not apply to the late AMD group).
11. Any periocular or intravitreal injections (IVT) in either eye (does not apply to the late AMD group).
12. Participation in any other interventional trial.
13. Obvious retinal changes due to causes other than AMD (e.g. evidenced by an existing diagnosis of monogenetic macular dystrophies, Stargardt disease, cone rod dystrophy, or toxic maculopathies).
14. Any history of allergies to fluorescein.;Intermediate AMD
1. Any GA in the study eye
2. Any extrafoveal GA larger than 1.25 mm2 (as defined above) in the fellow eye.
3. All general exclusion criteria.;Late AMD
1. All general exclusion criteria only.;Early AMD
1. Intermediate or late AMD (following Beckman classification) in any eye.
2. All general exclusion criteria.;No AMD
1. Early to late AMD (following Beckman classification) in any eye.
2. All general exclusion criteria.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified