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Trial · NCT02859441

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTabulation of Adverse EventsFrom Baseline to Week 52The total number of adverse events through Week 52.
SecondaryTabulation of Adverse EventsFrom Baseline to Week 104The total number of adverse events, excluding natural progression of disease events, through Week 104.
Secondary
The Proportion of Participants Experiencing Reduction in Size of at Least One Retinal Capillary Hemangioma (RCH), in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography (FA))
From Baseline to Week 52
The proportion of participants experiencing a reduction in size of at least one RCH in the study eye, in the absence of other ablative treatment as assessed by fundus photography and fluorescein angiography (FA), between Baseline and Week 52.
SecondaryThe Proportion of Participants Experiencing Reduction in Size of at Least One RCH, in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography [FA])From Baseline to Week 104
The proportion of participants experiencing a reduction in size of at least one RCH in the study eye, in the absence of other ablative treatment as assessed by fundus photography and fluorescein angiography (FA), between Baseline and Week 104.
SecondaryProportion of Participants Undergoing Ablative Treatment of RCH or Ocular SurgeryFrom Baseline to Week 52The proportion of participants undergoing ablative treatment of RCH or ocular surgery in the study eye between Baseline and Week 52.
SecondaryProportion of Participants Undergoing Ablative Treatment of RCH or Ocular SurgeryFrom Baseline to Week 104The proportion of participants undergoing ablative treatment of RCH or ocular surgery in the study eye between Baseline and Week 104.
SecondaryProportion of Participants With Successful Ablative Treatment of RCHFrom Baseline to Week 52The proportion of participants with successful ablative treatment of RCH in the study eye between Baseline and Week 52.
SecondaryProportion of Participants With Successful Ablative Treatment of RCHFrom Baseline to Week 104The proportion of participants with successful ablative treatment of RCH in the study eye between Baseline and Week 104.
SecondaryMean Change in Visual AcuityBaseline and Week 52
Mean change in visual acuity in the study eye from Baseline as compared to Week 52 as measured using the Electronic Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity (EVA) Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.
SecondaryMean Change in Visual AcuityBaseline and Week 104
Mean change in visual acuity in the study eye from Baseline as compared to Week 104 as measured using the Electronic Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity (EVA) Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.
SecondaryThe Proportion of Participants Experiencing Moderate Vision Loss (Defined as a Loss of Greater Than or Equal to 15 Letters From Baseline on Electronic Visual Acuity [EVA] Testing)From Baseline to Week 52
The proportion of participants experiencing moderate vision loss in the study eye (defined as a loss of greater than or equal to 15 letters from baseline on Electronic Visual Acuity \[EVA\] testing) between Baseline and Week 52.
SecondaryThe Proportion of Participants Experiencing Moderate Vision Loss (Defined as a Loss of Greater Than or Equal to 15 Letters From Baseline on Electronic Visual Acuity [EVA] Testing)From Baseline to Week 104
The proportion of participants experiencing moderate vision loss in the study eye (defined as a loss of greater than or equal to 15 letters from baseline on Electronic Visual Acuity \[EVA\] testing) between Baseline and Week 104.
SecondaryChange in Size of RCH (Measured by Fundus Photography and FA)From Baseline to Week 52Number of participants who experienced increased, decreased, or mixed change in the size of RCH in the study eye between Baseline and Week 52 (measured by fundus photography and FA).
SecondaryChange in Size of RCH (Measured by Fundus Photography and FA)From Baseline to Week 104Number of participants who experienced increased, decreased, or mixed change in the size of RCH in the study eye between Baseline and Week 104 (measured by fundus photography and FA).
SecondaryChange in Exudation (Measured by Fundus Photography, Optical Coherence Tomography (OCT) and FA)From Baseline to Week 52
Number of participants who experienced increased, decreased, or mixed change in exudation in the study eye between Baseline and Week 52 (measured by fundus photography, optical coherence tomography \[OCT\] and FA).
SecondaryChange in Exudation (Measured by Fundus Photography, Optical Coherence Tomography [OCT] and FA)From Baseline to Week 104
Number of participants who experienced increased, decreased, or mixed change in exudation in the study eye between Baseline and Week 104 (measured by fundus photography, optical coherence tomography \[OCT\] and FA).
SecondaryChange in Epiretinal Proliferation, Fibrosis or Retinal Traction (Assessed by OCT and Fundus Photography)From Baseline to Week 52
Number of participants who experienced increased, decreased, or mixed change in epiretinal proliferation, fibrosis or retinal traction in the study eye between Baseline and Week 52 (assessed by OCT and fundus photography).
SecondaryChange in Epiretinal Proliferation, Fibrosis or Retinal Traction (Assessed by OCT and Fundus Photography)From Baseline to Week 104
Number of participants who experienced increased, decreased, or mixed change in epiretinal proliferation, fibrosis or retinal traction in the study eye between Baseline and Week 104 (assessed by OCT and fundus photography).
SecondaryProportion of Participants With Appearance of One or More New RCHFrom Baseline to Week 52The proportion of participants with appearance of one or more new RCH in the study eye between Baseline and Week 52.
SecondaryProportion of Participants With Appearance of One or More New RCHFrom Baseline to Week 104The proportion of participants with appearance of one or more new RCH in the study eye between Baseline and Week 104.

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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