Trial · NCT03810313
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 | Baseline, Week 24 | Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment. | Letters read | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in BCVA Averaged Over Week 40 to Week 52 | Baseline, Week 40 to Week 52 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period. | Letters read | MEAN |
| SECONDARY | Change From Baseline in BCVA Averaged Over Week 64 to Week 76 | Baseline, Week 64 to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period. | Letters read | MEAN |
| SECONDARY | Change From Baseline in BCVA by Visit up to Week 76 | Baseline and every 4 weeks from baseline up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. | Letters read | MEAN |
| SECONDARY | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Baseline and every 4 weeks from baseline up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Baseline and every 4 weeks from baseline up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in CSFT Averaged Over Week 40 to Week 52 | Baseline, Week 40 to Week 52 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point | μm | MEAN |
| SECONDARY | Change From Baseline in CSFT Averaged Over Week 64 to Week 76 | Baseline, Week 64 to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point | μm | MEAN |
| SECONDARY | Change From Baseline in CSFT by Visit up to Week 76 | Baseline, and every 4 weeks from baseline up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit. | μm | MEAN |
| SECONDARY | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Every 4 weeks from week 4 up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 | Every 4 weeks from week 4 up to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had non-missing CSFT assessment at the corresponding visit | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Week 24 to Week 52 and Week 24 to Week 72 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who were on study treatment until week 52 and until week 72. | Injections | MEAN |
| SECONDARY | Time to Recurrence After Week 20 and up to Week 76 | Week 20 to Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed is the number of subjects from the FAS who did not discontinue from study treatment on or before Week 20. | Weeks | MEDIAN |
| SECONDARY | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Baseline to Week 76 | Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Baseline, Week 24, Week 52 and Week 76 | FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had NEI VFQ-25 assessment on scheduled visits. | Score on a scale | MEAN |
| SECONDARY | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | SAF-observed: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection with brolucizumab. The number analyzed is the number of subjects from the SAF who had a value for ADA status on scheduled visits. | Participants | COUNT_OF_PARTICIPANTS |
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
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GET https://conductscience.org/api/trials/v1/NCT03810313/outcomes