Inherited Retinal Degenerative Disease Registry

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 [email protected] 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]


Primary Outcome

Number of Participants with Rare Diagnoses Within the Inherited Retinal Degenerative Disease Category as Defined by Clinical Evaluation


Condition

Eye Diseases Hereditary



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

20000

Start Date

June 2014

Completion Date

June 2037

Primary Completion Date

June 2037

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Todd Durham, PhD, 800-683-5555, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02435940

Organization ID

FFB-Registry-01


Responsible Party

Sponsor

Study Sponsor

Foundation Fighting Blindness


Study Sponsor

Todd Durham, PhD, Principal Investigator, Vice President, Clinical and Outcomes Research


Verification Date

April 2021