Trial · NCT01840410
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Baseline, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in BCVA in Study Eye up to Month 2 | Baseline, Month 1, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFV was assessed OCT. A negative change from baseline indicates improvement. |
| Secondary | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | The presence of intra-retinal fluid was assessed by OCT. |
| Secondary | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | Presence of subretinal fluid in study eye compared to baseline |
| Secondary | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Month 2, Month 6, Month 12 | The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA). |
| Secondary | Average Change From Baseline in BCVA | Baseline (BL), Month 1 through Month 6, Month 1 through Month 12 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement. |
| Secondary | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Secondary | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Secondary | Number of Participants With Requirement for Rescue Treatment at Month 1 | Month 1 | Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1. |
| Secondary | Number of Participants With Ranibizumab Treatments in Study Eye | Month 12 | The number of participants administered study treatments, according to treatment frequency, was assessed. |
| Secondary | Number of Participants With Re-treatments | Month 12 | The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5. |
| Secondary | Number of Primary Reasons for Decision to Treat by Investigator | Month 12 | The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment. |
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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