Trial · NCT01585441
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | Month 3 | This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Primary | Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | Month 3 | This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume. |
| Secondary | Number of Participants With Adverse Reactions Related to the Investigational Product | Duration of the study, up to 1.5 years | The outcome measure refers only to events that were classified as related to the investigational product. |
| Secondary | Number of Participants Who Withdrew From the Study | Duration of the study, up to 1.5 years | |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | Month 3 | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline | Final Study Visit | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline | Month 3 | Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume. |
| Secondary | Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline | Month 3 | Microperimetry was used to assess macular sensitivity. |
| Secondary | Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline | Final Study Visit | Microperimetry was used to assess macular sensitivity. |
| Secondary | Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline | Month 3 | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). |
| Secondary | Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline | Final Study Visit | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). |
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | Month 3 | The mean change is reported in picograms of DHT per milliliter of serum. |
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline | Final Study Visit | The mean change is reported in picograms of DHT per milliliter of serum. |
| Secondary | Change in Serum Testosterone Concentration at Month 3 Compared to Baseline | Month 3 | The mean change is reported in nanograms of testosterone per decaliter of serum. |
| Secondary | Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline | Final Study Visit | The mean change is reported in nanograms of testosterone per decaliter of serum. |
| Secondary | Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline | Month 3 | The mean change is reported in micrograms (μg). |
| Secondary | Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline | Final Study Visit | The mean change is reported in micrograms (μg). |
| Secondary | Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline | Month 3 | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging |
| Secondary | Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline | Final Study Visit | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging |
| Secondary | Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline | Month 3 |
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/NCT01585441/registered