Clinical Trials in Italy / NCT03349801
Active, not recruiting
Observational
Development of Novel Clinical Endpoints in Intermediate AMD
NCT03349801 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Age Related Macular Degeneration (AMD)
Investigational drug(s) / intervention(s)
No intervention
No intervention: According to clinical practice.
Study summary
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
Eligibility
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.
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.
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.
2. All general inclusion criteria.
No AMD
1. No signs of early, intermediate or late AMD in both eyes.
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 (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 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.
Primary outcome measure(s)
- Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart — 3 years from baseline
standard parameter, tested for comparison (reference variable) - Mean change from baseline in scotopic and mesopic microperimetry sensitivity — 3 years from baseline
- Mean change from baseline in low luminance visual acuity (LLVA) — 3 years from baseline
- Mean change from baseline in vanishing optotypes visual acuity (VA) — 3 years from baseline
- Mean change from baseline in low luminance deficit (LLD) — 3 years from baseline
LLD = BCVA-LLVA - Mean change from baseline in absolute rod threshold of the dark adaptation test — 3 years from baseline
- Mean change from baseline in rod intercept time of the dark adaptation test — 3 years from baseline
- Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural — 3 years from baseline
- Mean change from baseline in the cube root of drusen volume by spectral-domain optical coherence tomography (SD-OCT) — 3 years from baseline
- Mean change from baseline in retinal thickness by spectral-domain optical coherence tomography (SD-OCT) — 3 years from baseline
- Focal pigmentary changes captured by colour fundus photography (CFP) — 3 years from baseline
- Presence of refractile deposits — 3 years from baseline
- Presence of intraretinal cystoid spaces — 3 years from baseline
- Presence of localized retinal pigment epithelium (RPE) hypertransmission — 3 years from baseline
- Presence of localized disruption of ellipsoid zone — 3 years from baseline
- Presence of localized subsidence of the outer plexiform layer and the inner nuclear layer — 3 years from baseline
- Presence of hyporeflective wedge-shaped bands — 3 years from baseline
- Presence of reticular drusen/subretinal drusenoid deposits and associated local changes as determined by multimodal imaging — 3 years from baseline
- Changes in localized fundus autofluorescence signal alterations — 3 years from baseline
- Proportion of subjects with reduction in drusen volume — 3 years from baseline
- Proportion of subjects with study eye that progressed to geogrphic atrophy (GA) and/or neovascular age-related macular degeneration (nAMD) — 3 years from baseline
- Proportion of subjects with conversions to late AMD detected with fluorescein angiography (FA) that could be detected with OCT-A (at equipped sites) — 3 years from baseline
- Presence of quiescent choroidal neovascularisation (CNV) as assessed by optical coherence tomography angiography (OCT-A) (at equipped sites) — 3 years from baseline
- OCT-A findings (at equipped sites) — 3 years from baseline
- Mean change from baseline in patient-reported low luminance visual functioning, as measured by the vision impairment in low luminance (VILL) questionnaire, including the domains of reading & accessing information — 3 years from baseline
- Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of Orientation & mobility (incl. driving) — 3 years from baseline
- Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of safety — 3 years from baseline
- Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of socio-emotional well-being — 3 years from baseline
- Change in utility index from baseline as measure by the patient-reported outcome measure (PROM) utility index — 3 years from baseline
- Mean change from baseline in patient-reported health status and utility using the EQ-5D-5L questionnaire (EuroQol Group) — 3 years from baseline
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Righospitalet Copenhagen | Copenhagen | Denmark | |
| Centre Hospitalier Intercommunal de Creteil | Créteil | France | |
| Centre d'Investigation Clinique Centre National d'Ophtalmologie des Quinze-Vingts | Paris | France | |
| University Hospital Bonn | Bonn | Germany | |
| University Hospital Cologne | Cologne | Germany | |
| Department of Ophthalmology, University of Freiburg | Freiburg im Breisgau | Germany | |
| University Eye Hospital Munich | Munich | Germany | |
| St. Franziskus Hospital | Münster | Germany | |
| Universtiy Hospital Tuebingen | Tübingen | Germany | |
| University Eye Hospital Ulm | Ulm | Germany | |
| Luigi Sacco Hospital | Milan | Italy | |
| Ospedale San Raffaele | Milan | Italy | |
| G.B.Bietti Eye Foundation | Rome | Italy | |
| Radboud University Medical Centre | Leiden | Netherlands | |
| Radboud University Medical Centre | Nijmegen | Netherlands | |
| Centre for Clinical Trials, AIBILI | Coimbra | Portugal | |
| Centro Hospitalar de São João, E.P.E. | Porto | Portugal | |
| Queen's University Belfast | Belfast | United Kingdom | |
| Gloucestershire Hospitals NHS Foundation Trust | Gloucester | United Kingdom | |
| Moorfields Eye Hospital | London | United Kingdom |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03349801 on ClinicalTrials.gov ↗ ← All trials in Italy