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Trial · NCT01251978

Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

NCT01251978, Phase 2, Completed, New England Retina Associates; results first posted 2016-10-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2). Trials, record NCT01251978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01251978

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Trial

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

Title
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
NCT number
NCT01251978
Status
Completed
Phases
Phase 2
Enrollment
10 participants, actual
Lead sponsor
New England Retina Associates
Conditions
Choroidal Melanoma
Interventions
Ranibizumab 2 mg, 0.5 mg Ranibizumab
First posted
2010-12-02
Last updated
2016-10-19
Results first posted
2016-10-19

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
Primary
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
1 year
SecondaryTumor Thicknessbaseline and 1 year
SecondaryVisual Acuity (LogMar)12 months

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
1 yearcomplications were only assessed in the high dose groupparticipantNUMBER
SECONDARYTumor Thicknessbaseline and 1 yearmillimeters (mm)MEAN
SECONDARYVisual Acuity (LogMar)12 monthsLogMarNUMBER

Results by group25

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

OutcomeGroupCategoryValueSpreadUnits
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
High Dose Ranibizumabvascular occlusion4participant
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
High Dose Ranibizumabretinal detachment1participant
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
High Dose Ranibizumabpersistent sub retinal fluid (srf)1participant
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
High Dose RanibizumabCME1participant
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
High Dose Ranibizumabmetastatic death1participant
Tumor ThicknessHigh Dose Ranibizumabbaseline4.85Full Range 2.5 to 7.48millimeters (mm)
Tumor ThicknessStandard Dose Ranibizumabbaseline2.91Full Range 2.5 to 3.5millimeters (mm)
Tumor ThicknessHigh Dose Ranibizumab12 month2.68Full Range NA to NAmillimeters (mm)
Tumor ThicknessStandard Dose Ranibizumab12 month0.79Full Range NA to NAmillimeters (mm)
Visual Acuity (LogMar)High Dose RanibizumabPatient 01NALogMar

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDHigh Dose Ranibizumab5
Overall StudySTARTEDStandard Dose Ranibizumab3
Overall StudyCOMPLETEDHigh Dose Ranibizumab5
Overall StudyCOMPLETEDStandard Dose Ranibizumab3
Overall StudyNOT COMPLETEDHigh Dose Ranibizumab0
Overall StudyNOT COMPLETEDStandard Dose Ranibizumab0

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityHigh Dose Ranibizumab
Total, all-cause mortalityStandard Dose Ranibizumab
Total, other adverse eventsHigh Dose Ranibizumab00
Total, other adverse eventsStandard Dose Ranibizumab00
Total, serious adverse eventsHigh Dose Ranibizumab00
Total, serious adverse eventsStandard Dose Ranibizumab00

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 comparisons0

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

None in this release.

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/NCT01251978

GET https://conductscience.org/api/trials/v1/NCT01251978/results?page=2