Active — Not RecruitingNot Applicable

Development of Novel Clinical Endpoints in Intermediate AMD

Denmark, France, Germany718 participantsStarted 2018-03-26

Plain-language 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

Who can participate

Age range55 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female subjects.
✓. Aged 55 - 85 years at baseline.
✓. Able and willing to provide written informed consent and to comply with the study protocol visits and assessments.
✓. Study eye must have iAMD and,
✓. 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.
✓. ETDRS letter chart BCVA in the study eye not worse than 72 letters (approximately 20/40 Snellen VA equivalent).
✓. All general inclusion criteria.
✓. Subjects with bilateral GA, bilateral nAMD or nAMD in one eye and GA in the other.

Exclusion criteria

✕. Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator.
✕. Severe ptosis, extraocular motility restriction or head tremor preventing adequate fundus visualization in the opinion of the investigator.
✕. Any signs of nAMD or GA (does not apply to the late AMD group).
✕. 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.
✕. Severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
✕. Any diabetic macular edema or macular disease
✕. 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.
✕. Diagnosis of uncontrolled glaucoma with intraocular pressure of \>30 mmHg (despite current pharmacological or non-pharmacological treatment).

What they're measuring

Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart

Timeframe: 3 years from baseline

Mean change from baseline in scotopic and mesopic microperimetry sensitivity

Timeframe: 3 years from baseline

Mean change from baseline in low luminance visual acuity (LLVA)

Timeframe: 3 years from baseline

Mean change from baseline in vanishing optotypes visual acuity (VA)

Timeframe: 3 years from baseline

Mean change from baseline in low luminance deficit (LLD)

Timeframe: 3 years from baseline

Mean change from baseline in absolute rod threshold of the dark adaptation test

Timeframe: 3 years from baseline

Mean change from baseline in rod intercept time of the dark adaptation test

Timeframe: 3 years from baseline

Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural

Trial details

NCT IDNCT03349801

SponsorFrank G. Holz

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Age Related Macular Degeneration (AMD) trials

Who can participate

Age range55 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female subjects.
✓. Aged 55 - 85 years at baseline.
✓. Able and willing to provide written informed consent and to comply with the study protocol visits and assessments.
✓. Study eye must have iAMD and,
✓. 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.
✓. ETDRS letter chart BCVA in the study eye not worse than 72 letters (approximately 20/40 Snellen VA equivalent).
✓. All general inclusion criteria.
✓. Subjects with bilateral GA, bilateral nAMD or nAMD in one eye and GA in the other.

Exclusion criteria

✕. Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator.
✕. Severe ptosis, extraocular motility restriction or head tremor preventing adequate fundus visualization in the opinion of the investigator.
✕. Any signs of nAMD or GA (does not apply to the late AMD group).
✕. 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.
✕. Severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
✕. Any diabetic macular edema or macular disease
✕. 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.
✕. Diagnosis of uncontrolled glaucoma with intraocular pressure of \>30 mmHg (despite current pharmacological or non-pharmacological treatment).

What they're measuring

Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart

Timeframe: 3 years from baseline

Mean change from baseline in scotopic and mesopic microperimetry sensitivity

Timeframe: 3 years from baseline

Mean change from baseline in low luminance visual acuity (LLVA)

Timeframe: 3 years from baseline

Mean change from baseline in vanishing optotypes visual acuity (VA)

Timeframe: 3 years from baseline

Mean change from baseline in low luminance deficit (LLD)

Timeframe: 3 years from baseline

Mean change from baseline in absolute rod threshold of the dark adaptation test

Timeframe: 3 years from baseline

Mean change from baseline in rod intercept time of the dark adaptation test

Timeframe: 3 years from baseline

Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural