NCT04558983Terminated
A Natural History Study to Evaluate Functional and Anatomical Progression in Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
This study will assess the progression of RP as seen on newer modalities including spectral-domain optical coherence (SD-OCT) and macular assessment integrity (MAIA) microperimetry to evaluate disease status. Understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. It is also fundamental in the predevelopment phase in order to optimize the study duration needed to observe a statistically significant outcome. Furthermore, since the progression of RP is usually slow, relying on traditional tests can take an unfeasible length of time to observe any meaningful changes and assess therapeutic efficacy for new drugs. Therefore, the results of this study will be beneficial in establishing reliable endpoints and outcome measures for future clinical trials. Such outcome measures may be able to detect treatment response with more precision. More importantly, investigators may be able to detect changes early enough to prevent irreversible vision loss.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 16 Sept 2020
- Start date
- 11 Jun 2020
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT04558983
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant ocular pathology that limits central macular function, including but not limited to age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion
Other
- If EZ width ≤200µm
Who the study is looking for
- Age 18 years or older
- Patients diagnosed with Retinitis Pigmentosa
- Ability to provide informed consent
- Ability to authorize use and disclosure of protected health information
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wilmer Eye Institute at Johns Hopkins University | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.