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Inherited Retinal Degenerative Disease Registry (MRTR)

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ClinicalTrials.gov Identifier: NCT02435940
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Foundation Fighting Blindness

Tracking Information
First Submitted Date April 3, 2015
First Posted Date May 6, 2015
Last Update Posted Date May 4, 2021
Study Start Date June 2014
Estimated Primary Completion Date June 2037   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2017)
Number of Participants with Rare Diagnoses Within the Inherited Retinal Degenerative Disease Category as Defined by Clinical Evaluation [ Time Frame: Data collection is ongoing, up to 20 years. ]
Participant profiles broken out be disease category and genetic diagnosis
Original Primary Outcome Measures
 (submitted: May 1, 2015)
Number of Participants with Rare Diagnoses Within the Inherited Retinal Degenerative Disease Category as Defined by Clinical Evaluation [ Time Frame: Data collection is ongoing, up to 20 years. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Inherited Retinal Degenerative Disease Registry
Official Title Foundation Fighting Blindness My Retina Tracker Registry
Brief Summary The My Retina Tracker® Registry is sponsored by the Foundation Fighting Blindness and is for people affected by one of the rare inherited retinal degenerative diseases studied by the Foundation. It is a patient-initiated registry accessible via a secure on-line portal at www.MyRetinaTracker.org. Affected individuals who register are guided to create a profile that captures their perspective on their retinal disease and its progress; family history; genetic testing results; preventive measures; general health and interest in participation in research studies. The participants may also choose to ask their clinician to add clinical measurements and results at each clinical visit. Participants are urged to update the information regularly to create longitudinal records of their disease, from their own perspective, and their clinical progress. The overall goals of the Registry are: to better understand the diversity within the inherited retinal degenerative diseases; to understand the prevalence of the different diseases and gene variants; to assist in the establishment of genotype-phenotype relationships; to help understand the natural history of the diseases; to help accelerate research and development of clinical trials for treatments; and to provide a tool to investigators that can assist with recruitment for research studies and clinical trials.
Detailed Description

My Retina Tracker Registry provides two portals for data entry and review. Initial registration in the My Retina Tracker Registry is initiated by a participant, not a clinician. Using the participant portal, the participant establishes a username and password, is guided through on-line informed consent, and can then use an interactive guide to record their ophthalmic and family history, genotype and other subjective diagnosis-related and general health information. Drop-down menus and standardized vocabulary are used for database consistency. They may also attach documents, such as medical records, to maintain their personal medical files on their disease. Participants are encouraged to update their profiles regularly to create a longitudinal history of their disease. Participants can see aggregated data for all other participants in the registry and compare their own disease and status to others.

After a profile has been established, Registry members may ask their clinician or genetic counselor to add specific ophthalmic exam and measurement results to the profile. This is done through the clinical portal which also uses a series of drop-down menus to expedite entry and standardize data. Clinicians cannot see the participant data when adding the clinical exam data. Participants are encouraged to collect this data at each medical exam, to create a longitudinal clinical data set.

Access to de-identified data or study recruitment assistance is available to qualified investigators who may inquire by contacting Coordinator@MyRetinaTracker.org. A process that maintains patient anonymity and privacy protection, exists for researchers with Institutional Review Board-approved projects who wish to contact registry participants of interest.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Affected individuals, all ages including minors registered by their parent or guardian.
Condition
  • Eye Diseases Hereditary
  • Retinal Disease
  • Achromatopsia
  • Bardet-Biedl Syndrome
  • Bassen-Kornzweig Syndrome
  • Batten Disease
  • Best Disease
  • Choroidal Dystrophy
  • Choroideremia
  • Cone Dystrophy
  • Cone-Rod Dystrophy
  • Congenital Stationary Night Blindness
  • Enhanced S-Cone Syndrome
  • Fundus Albipunctatus
  • Goldmann-Favre Syndrome
  • Gyrate Atrophy
  • Juvenile Macular Degeneration
  • Kearns-Sayre Syndrome
  • Leber Congenital Amaurosis
  • Refsum Syndrome
  • Retinitis Pigmentosa
  • Retinitis Punctata Albescens
  • Retinoschisis
  • Rod-Cone Dystrophy
  • Rod Dystrophy
  • Rod Monochromacy
  • Stargardt Disease
  • Usher Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 1, 2015)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2037
Estimated Primary Completion Date June 2037   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed with an inherited retinal degenerative disease OR

Exclusion Criteria:

  • Glaucoma only
  • Diabetic retinopathy only
  • Non-retinal disease
  • Not heritable retinal disease
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Registry Coordinator 800-683-5555 ext 1594 Coordinator@MyRetinaTracker.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02435940
Other Study ID Numbers FFB-Registry-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Foundation Fighting Blindness
Study Sponsor Foundation Fighting Blindness
Collaborators Not Provided
Investigators
Principal Investigator: Todd Durham, PhD Vice President, Clinical and Outcomes Research
PRS Account Foundation Fighting Blindness
Verification Date April 2021