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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05300724




Registration number
NCT05300724
Ethics application status
Date submitted
18/03/2022
Date registered
29/03/2022

Titles & IDs
Public title
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Scientific title
A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Secondary ID [1] 0 0
2022-000046-15
Secondary ID [2] 0 0
GE43220
Universal Trial Number (UTN)
Trial acronym
HONU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Intermediate AMD - Participants with iAMD will be evaluated for the progression of iAMD to more advanced atrophic AMD stages, such as nascent geographic atrophy (nGA) or incomplete retinal pigment epithelium and outer retinal atrophy (iRORA), and subsequently from nGA or iRORA to complete retinal pigment epithelium (cRORA) and outer retinal atrophy or geographic atrophy (GA), on Day 1 and thereafter every 12 weeks up to the end of the Observation Period, approximately 3 years.


Other interventions: No intervention
No intervention will be administered in this study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Conversion from iAMD to nGA /iRORA
Timepoint [1] 0 0
Baseline up to 3 years
Primary outcome [2] 0 0
Rate of Conversion from nGA/iRORA to cRORA/GA
Timepoint [2] 0 0
Baseline up to 3 years
Primary outcome [3] 0 0
Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Timepoint [3] 0 0
Baseline up to 3 years

Eligibility
Key inclusion criteria
* For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the study for at least 28 days after the last fluorescein injection for the fluorescein angiography (FA) administration
* Study eye: High-risk intermediate AMD
Minimum age
50 Years
Maximum age
94 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Macular disease in either eye with subretinal deposits not typical of AMD
* Pigmentary abnormalities of the retina in either eye not typical of AMD
* Atrophy in either eye due to causes other than AMD
* Study eye: Any concurrent or history of ocular or intraocular condition
* Study eye: Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
* Study eye: Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
* Study eye: Concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
* Study eye: Presence of choroidal nevus with overlying drusen in the circle with a radius 3600 micrometer centered on the fovea
* Study eye: Previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals, regardless of the route of administration within the last 6 months, except for sham-arm participants
* Study eye: History of glaucoma surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
* Either eye: Uncontrolled progressive glaucoma
* Either eye: Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
* Either eye: History of recurrent infectious or inflammatory ocular disease
* Any concurrent or history of taking medications that can induce retinal toxicity

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Marsden Eye Specialists - Parramatta
Recruitment hospital [2] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [4] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [5] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [6] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Wisconsin
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France
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Creteil
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France
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Ecully
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France
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Grenoble
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France
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Lyon
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France
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Paris
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France
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Strasbourg
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Germany
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Bonn
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Germany
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Freiburg
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Germany
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Gottingen
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Germany
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Hannover
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Germany
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Leipzig
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Germany
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Münster
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Germany
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Tübingen
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Aviv-Yafo
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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Puerto Rico
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Arecibo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GE43220 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05300724