Trial · NCT05203939
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study Drug-related adverse events (SDAE) | 1 year | Counts, frequencies and percentages of SDAEs. SDAE is a primary adverse event of interest and defined as AEs and SAEs that are direct subjects to the Study Drug only. |
| Primary | Treatment-Emergent adverse events (TEAEs) | 1 year | Counts, frequencies and percentages TEAEs. TEAEs are defined as an event that was not present prior to administration of the dose of study drug and present after the dose, or if it represents the exacerbation of an event that was present prior to the dose. |
| Primary | Serious adverse events (SAEs) | 1 year | Counts, frequencies and percentages of SAEs including Resulted in Death, Life-threatening, Hospitalization, Disabling/incapacitating, Congenital anomaly or birth defect and medically significant AEs ( AE that did not meet any of the above criteria but could have jeopardized the subject and might have required medical or surgical intervention to prevent one of the outcomes listed above). |
| Secondary | Best-corrected visual acuity (BCVA) | 1 year (Changes from baseline) | Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts. Electronic ETDRS Visual Acuity Testing Protocol will be followed (confidential). |
| Secondary | Low-luminance visual acuity (LLVA) | 1 year (Changes from baseline) | Electronic Visual Acuity Tester (EVA) and a Sponsor specific Low-Luminance lens will be used. Early Treatment of Diabetic Retinopathy Study (ETDRS) will also be accepted as a backup. |
| Secondary | Slit-lamp biomicroscopy | 1 year (Changes from baseline) | Changes in visual function. |
| Secondary | Intraocular pressure (IOP) | 1 year (Changes from baseline) | IOP measurement by applanation or rebound tonometry. Confirmation with Goldmann tonometer if IOP reading is outside the normal range (8-21mmHg). |
| Secondary | Indirect ophthalmoscopy | 1 year (Changes from baseline) | If visual acuity is so poor that the participant is unable to count fingers or perceive hand motion, light perception will be tested with the indirect ophthalmoscope as the light source. |
| Secondary | anti-AAV5 (anti Adeno-associated virus type 5) | 1 year | Blood samples will be collected for the assessment. These samples will be analyzed using validated assays at a bioanalytical laboratory. |
| Secondary | anti-hNR2E3 antibodies (hNR2E3 gene) | 1 year | Blood samples will be collected for the assessment. These samples will be analyzed using validated assays at a bioanalytical laboratory. |
| Secondary | T-cell response | 1 year | Blood samples will be collected for the assessment. These samples will be analyzed using validated assays at a bioanalytical laboratory. |
| Other | Multi-luminance mobility testing (MLMT) | 1 year (Changes from baseline) | Subjects will navigate a standardized mobility maze under set conditions as specified times during the study. The mobility testing will follow a standardized administration and data acquisition protocol and may only be administered by site staff certified in the methodology. |
| Other | Changes in ellipsoid zone width/length on wide-field 20° SD-OCT | 1 year (Changes from baseline) | Ellipsoid zone area/outer segment length will be determined by Spectral Domain Optical Coherence Tomography (SD-OCT) using standardized systems and acquisition protocols. |
| Other | Contrast sensitivity | 1 year (Changes from baseline) | Contrast sensitivity will be conducted using Pelli-Robson chart. |
| Other | Full Field Light Stimulation Threshold (FST) | 1 year (Changes from baseline) | FST will be completed at scheduled times throughout the study period |
| Other | Photopic Static Visual Fields | 1 year (Changes from baseline) | The Octopus 900 will be used with a standardized white-on-white full field and a blue-on-yellow with full field |
| Other | Vision on Quality of Life | 1 year (Changes from baseline) | The National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ25) and the Michigan Retinal Degeneration Questionnaire (MRDQ) questionnaires (for RP Adult subjects only) will be administered to assess the impact of vision on quality of subject's life. |
| Other | Full Field Electroretinogram | 1 year (Changes from baseline) | The International Society for Clinical Electrophysiology of Vision (ISCEV) guidelines will be followed for conducting ff-ERG (Full-field Electroretinography) for RP subjects only. |
| Other | Wide-field fundus autofluorescence (wf-FAF) | 1 year (Changes from baseline) | The intensity of FAF will be evaluated using 55° posterior pole scanning. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05203939/registered