In Depth Observational Clinical Trial Of Retinitis Pigmentosa Patients
Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05849987
Collaborator
(none)
500
24
Study Details
Study Description
Brief Summary
Typically, clinical research participation favors a specific demographic group, and little research exists on how trial attributes affect participation. As such, this study seeks to analyze data from different demographic groups and check for recurring trends that could provide valuable insights for future retinitis pigmentosa patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Retinitis Pigmentosa Clinical Study: Examining the Clinical Trial Journey of Retinitis Pigmentosa Patients
Anticipated Study Start Date
:
May 1, 2024
Anticipated Primary Completion Date
:
May 1, 2025
Anticipated Study Completion Date
:
May 1, 2026
Outcome Measures
Primary Outcome Measures
- Number of patient decides to enroll in clinical trial [3 months]
- Rate of patients who remain in clinical trial to trial completion [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Is 18+ years old
-
Confirmed diagnosis of retinitis pigmentosa
-
Signed Written Informed Consent
Exclusion Criteria:
-
Inability to perform regular electronic reporting
-
Participant is actively receiving study therapy in another trial
-
Women of childbearing potential without a negative pregnancy test; or women who are lactating.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Arslan U, Ozmert E, Demirel S, Ornek F, Sermet F. Effects of subtenon-injected autologous platelet-rich plasma on visual functions in eyes with retinitis pigmentosa: preliminary clinical results. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):893-908. doi: 10.1007/s00417-018-3953-5. Epub 2018 Mar 15.
- Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.
- Miura G, Sugawara T, Kawasaki Y, Tatsumi T, Nizawa T, Baba T, Hanaoka H, Yamamoto S. Clinical Trial to Evaluate Safety and Efficacy of Transdermal Electrical Stimulation on Visual Functions of Patients with Retinitis Pigmentosa. Sci Rep. 2019 Aug 12;9(1):11668. doi: 10.1038/s41598-019-48158-5.
Responsible Party:
Power Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT05849987
Other Study ID Numbers:
- 92030990
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Power Life Sciences Inc.
Additional relevant MeSH terms: