Inherited Retinal Degenerative Disease Registry

Foundation Fighting Blindness Registry, My Retina Tracker


Lead Sponsor: Foundation Fighting Blindness

Source Foundation Fighting Blindness
Brief Summary

My Retina Tracker® is a registry for people affected by an inherited retinal degenerative disease. It is a patient-initiated registry accessible via a secure on-line portal at Affected individuals and genetically related, unaffected, family members who create entries are guided to create a profile that captures the participants' perspective on their disease and its progress; family history; genetic testing results; preventive measures; 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 are: to better understand the heterogeneity of the inherited retinal degenerative diseases; to understand the prevalence of the different diseases and gene mutations; 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 mechanism that facilitates more rapid recruitment for research studies and clinical trials.

Detailed Description

My Retina Tracker provides three different portals for data entry and review. An entry in My Retina Tracker 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 information. Drop-down menus and standardized vocabulary are used for database consistency. They may also attach documents, such as medical records, to maintain personal 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. Once a participant profile has been established, participants 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 is available through the Research Portal. Investigators may apply through the site for research access username and password. This access allows searching of both participant provided and clinical data and may also be used to pre-screen registrants as potential participants for research studies or clinical trials. 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.

Overall Status Recruiting
Start Date June 2014
Completion Date June 2037
Primary Completion Date June 2037
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Number of Participants with Rare Diagnoses Within the Inherited Retinal Degenerative Disease Category as Defined by Clinical Evaluation Data collection is ongoing, up to 20 years.
Enrollment 20000

Sampling Method: Probability Sample


Inclusion Criteria: - Diagnosed with an inherited retinal degenerative disease OR - Genetically-related to a person diagnosed with an inherited retinal degenerative disease Exclusion Criteria: - Glaucoma - Diabetic retinopathy - Non-retinal disease, - Not heritable retinal disease

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Brian Mansfield, PhD Principal Investigator Deputy Chief Research Officer
Overall Contact

Last Name: Registry Coordinator

Phone: 800-683-5555

Email: [email protected]

Facility: Status: Contact: Investigator: Foundation Fighting Blindness Joan Fisher 800-683-5555 [email protected] Brian Mansfield, PhD Principal Investigator
Location Countries

United States

Verification Date

December 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Other

Time Perspective: Prospective


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