Trial · NCT07342439
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | EZ loss | Baseline through Month 24 | Mean rate of change in the total area of EZ loss (IS/OS; macular photoreceptor loss) from Baseline (BL) through Month 24 (M24), as assessed using SD-OCT in the study eye(s). |
| Secondary | EZ loss at different time points | Baseline through Month 12 and 24 | Mean rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from BL through Month 12 (M12) in the study eye(s) and through M12 and M24 in the fellow eye, as assessed using SD-OCT |
| Secondary | Changes in Disease Severity | Baseline through Month 24 | Changes in disease severity (stages, according to Chew et al) in study eye(s), and fellow eye, from BL to M24 |
| Secondary | Retinal Sensitivity Loss | Baseline through Month 24 | Mean change in retinal sensitivity loss as measured by Macular Integrity Assessment (MAIA) from BL to M24 in study eye(s), and fellow eye |
| Secondary | Reading Speed | Baseline through Month 24 | Mean change in monocular and binocular reading speed assessed using International Reading Speed Texts (IReST) cards from BL through M24 in the study eye(s), and fellow eye |
| Secondary | Contrast Sensitivity | Baseline through Month 24 | Mean change in monocular contrast sensitivity from BL to M24 in the study eye(s) and fellow eye as assessed by Pelli-Robson contrast sensitivity charts |
| Secondary | Low Luminance Visual Acuity | Baseline through Month 24 | Mean change in monocular low luminance visual acuity (LLVA) scores from BL to M24 in the study eye(s) and fellow eye as assessed by ETDRS charts |
| Secondary | Low Luminance Deficit | Baseline through Month 24 | Mean change in low luminance deficit (LLVA - BCVA) from BL to M24 in the study eye(s) and fellow eye |
| Secondary | Best Corrected Visual Acuity | Baseline through Month 24 | Mean change in monocular best-corrected visual acuity (BCVA) scores from BL to M24 in the study eye(s) and fellow eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) charts |
| Secondary | Corneal Nerve fiber Density | Baseline through Month 6, 12, 18 and 24 | Mean change in corneal nerve fiber and branch density (biomarkers of peripheral nerve health) from BL to M6, M12, M18 and M24 in the study eye(s) and fellow eye |
| Secondary | HbA1c | Baseline through Months 12 and 24 | Mean change in HbA1c from BL to M12 and M24 |
| Secondary | BMI | Baseline through Months 12 and 24 | Mean change in BMI (weight and height will be combined to report BMI in kg/m\^2) from BL to M12 and M24 |
| Secondary | Serum Metabolites | Baseline through Months 12 and 24 | Mean changes in fasted serum metabolite values from BL to M12 and M24 |
| Secondary | MacTel Metabolic Signature | Baseline through Months 12 and 24 | Mean changes in composite serum metabolic score measuring the global "MacTel Metabolic signature" from BL to M12 and M24 |
| Secondary | NEI VFQ-25 | Baseline through Month 12 and 24 | Mean change in NEI VFQ-25 scores from BL to M12 and M24 |
| Secondary | VILL-33 | Baseline through Months 12 and 24 | Mean change in VILL-33 scores from BL to M12 and M24 |
| Secondary | TEAEs and SAEs | Baseline through Month 24 | Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and ocular TEAEs and SAEs |
| Secondary | ETDRS Letter Score | Baseline through Month 24 | Number of study eyes, fellow eyes with \>= 15 letter loss (ETDRS letter score), \>= 10 letter loss and \>= 5 letter loss from BL to M24 |
| Secondary | Neovascularization | Baseline through Month 24 | Total number of study eyes, fellow eyes showing a de novo development of neovascularization from BL to M24 |
| Secondary | Outer Retinal Hyper-Reflectivity | Baseline through Month 24 | Total number of study eyes, fellow eyes showing a de novo development of outer retinal hyper-reflectivity from BL to M24 |
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.
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GET https://conductscience.org/api/trials/v1/NCT07342439/registered