Trial · NCT05019521
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change From Baseline to Week 52 in the Square Root (Sqrt) of Total Geographic Atrophy (GA) Lesion Area in the Study Eye as Measured by Fundus Autofluorescence (FAF) | Baseline, Week 52 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) who had any post-baseline FAF GA lesion area data at the Week 52 analysis. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. | mm/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 104 in the Sqrt of the Total GA Lesion Area in the Study Eye as Measured by FAF | Baseline, Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline visit and post-baseline (Week 104) visit FAF GA lesion area data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. | mm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in the Total GA Lesion Area in the Study Eye as Measured by FAF | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit FAF GA lesion area data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints. | mm^2 | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT) | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ total attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ partial attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit ONL-RPE mean central 1 mm subfield thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | micrometers (µm) | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit ONL-RPE mean central macular 2 mm thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | µm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE macular volume data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | cubic millimeters (mm^3) | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE mean central 1 mm subfield thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | µm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE mean central macular 2 mm thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | µm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ total attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ partial attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ total attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of EZ partial attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit sub-RPE central 1 mm subfield mean thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | µm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (randomized participants who received at least 1 dose \[full/partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit sub-RPE central macular 2 mm subfield mean thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | µm | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit panmacular sub-RPE volume data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | mm^3 | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit macular total RPE attenuation data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of macular area | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit central 1 mm subfield total RPE attenuation data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories. | percentage of total RPE attenuation | MEAN |
| SECONDARY | Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT | Baseline, Week 52 and Week 104 | All participants in FAS (all randomized participants who received at least 1 dose \[full/partial\] of study drug grouped by randomized treatment) with both baseline and postbaseline (Week 52 and Week 104) visit central macular 2 mm subfield total RPE attenuation data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed= participants evaluable for specified categories. | percentage of total RPE attenuation | MEAN |
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.
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