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Trial · NCT01003106

Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

NCT01003106, Phase 1, Phase 2, Completed, Peter A Campochiaro, MD; results first posted 2016-03-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions. Trials, record NCT01003106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01003106

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
NCT number
NCT01003106
Status
Completed
Phases
Phase 1, Phase 2
Enrollment
81 participants, actual
Lead sponsor
Peter A Campochiaro, MD
Conditions
Retinal Vein Occlusion
Interventions
Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly), Pro re nata (prn) ranibizumab, Pro re nata (prn) Laser photocoagulation
First posted
2009-10-28
Last updated
2016-03-15
Results first posted
2016-03-15

Source ClinicalTrials.gov

Registered outcomes5

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

ListOutcomeTime frameDescription
PrimaryIncidence and Severity of Ocular and Non-ocular Adverse Events.36 months
SecondaryMean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBaseline to month 6
SecondaryMean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.Month 6- Month 36
SecondaryMean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBaseline to month 6
SecondaryMean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.Month 6- Month 36

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence and Severity of Ocular and Non-ocular Adverse Events.36 monthsparticipantsNUMBER
SECONDARYMean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBaseline to month 6LettersMEAN
SECONDARYMean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.Month 6- Month 36LettersMEAN
SECONDARYMean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBaseline to month 6micronsMEAN
SECONDARYMean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.Month 6- Month 36micronsMEAN

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Incidence and Severity of Ocular and Non-ocular Adverse Events.BRVOPatients with Serious Adverse Events17participants
Incidence and Severity of Ocular and Non-ocular Adverse Events.CRVOPatients with Serious Adverse Events12participants
Incidence and Severity of Ocular and Non-ocular Adverse Events.BRVOPatient with (non serious) adverse events37participants
Incidence and Severity of Ocular and Non-ocular Adverse Events.CRVOPatient with (non serious) adverse events35participants
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBRVO-Ranibizumab 0.5mg Alone12.1Standard Error 2.9Letters
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabBRVO- Ranibizumab 2.0mg Alone14.6Standard Error 2.3Letters
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabCRVO- Ranibizumab 0.5mg Alone15.5Standard Error 2.4Letters
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of RanibizumabCRVO- Ranibizumab 2.0mg Alone15.8Standard Error 2.4Letters
Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.BRVO- Pro re Nata (Prn) Ranibizumab Alone3.1Standard Error 3.3Letters
Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation-2.6Standard Error 2.2Letters

Participant flow48

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Baseline to Month 6STARTEDBRVO- Ranibizumab 0.5mg Alone22
Baseline to Month 6STARTEDBRVO- Ranibizumab 2.0mg Alone20
Baseline to Month 6STARTEDBRVO- Pro re Nata (Prn) Ranibizumab Alone0
Baseline to Month 6STARTEDBRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation0
Baseline to Month 6STARTEDCRVO- Ranibizumab 0.5mg Alone19
Baseline to Month 6STARTEDCRVO- Ranibizumab 2.0mg Alone20
Baseline to Month 6STARTEDCRVO- Pro re Nata (Prn) Ranibizumab Alone0
Baseline to Month 6STARTEDCRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation0
Baseline to Month 6COMPLETEDBRVO- Ranibizumab 0.5mg Alone22
Baseline to Month 6COMPLETEDBRVO- Ranibizumab 2.0mg Alone20

Adverse events94

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherIncreased IOPEye disordersBRVO2422
otherIncreased IOPEye disordersCRVO0390
otherTooth ExtractionGeneral disordersBRVO3423
otherTooth ExtractionGeneral disordersCRVO0390
otherSkin Lesion/Skin RashSkin and subcutaneous tissue disordersBRVO4424
otherSkin Lesion/Skin RashSkin and subcutaneous tissue disordersCRVO0390
otherDiarrheaGastrointestinal disordersBRVO2422
otherDiarrheaGastrointestinal disordersCRVO0390
otherNausea/VomitingGastrointestinal disordersBRVO4424
otherNausea/VomitingGastrointestinal disordersCRVO0390

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityBRVO
Total, all-cause mortalityCRVO
Total, other adverse eventsBRVO3742
Total, other adverse eventsCRVO3539
Total, serious adverse eventsBRVO1742
Total, serious adverse eventsCRVO1239

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
BRVO vs CRVO: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01003106

GET https://conductscience.org/api/trials/v1/NCT01003106/flow?page=2