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

Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01251978
Enrollment
10
Registered
2010-12-02
Start date
2010-07-31
Completion date
2012-08-31
Last updated
2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Melanoma

Keywords

Choroidal melanoma, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green

Brief summary

Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

Interventions

DRUGRanibizumab 2 mg

intravitreal injections of ranibizumab once a month, times 3.

DRUG0.5 mg Ranibizumab

6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
New England Retina Associates
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 18 years or older * Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height. * Location of the tumor, posterior to the equator of the eye. * Documented growth of tumor by A-B scan. * Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion criteria

* Pregnancy or lactation. * Premenopausal women not using adequate contraception. * Current infection or inflammation in either eye. * Extension of tumor into the orbit. * Regional spread or metastatic disease. * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * Any known allergy to any of the components to be used in the study. * Participation in another simultaneous medical investigation or trial.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Tumor Thicknessbaseline and 1 year
Visual Acuity (LogMar)12 months

Countries

United States

Participant flow

Pre-assignment details

10 participants were enrolled - 2 participants were eliminated early in the study for non compliance.

Participants by arm

ArmCount
High Dose Ranibizumab
patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3.
5
Standard Dose Ranibizumab
patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. 0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
3
Total8

Baseline characteristics

CharacteristicHigh Dose RanibizumabStandard Dose RanibizumabTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants0 Participants4 Participants
Age, Categorical
Between 18 and 65 years
1 Participants3 Participants4 Participants
Sex: Female, Male
Female
2 Participants2 Participants4 Participants
Sex: Female, Male
Male
3 Participants1 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: 1 year

Population: complications were only assessed in the high dose group

ArmMeasureGroupValue (NUMBER)
High Dose RanibizumabTo 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.vascular occlusion4 participant
High Dose RanibizumabTo 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.retinal detachment1 participant
High Dose RanibizumabTo 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.persistent sub retinal fluid (srf)1 participant
High Dose RanibizumabTo 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.CME1 participant
High Dose RanibizumabTo 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.metastatic death1 participant
Secondary

Tumor Thickness

Time frame: baseline and 1 year

ArmMeasureGroupValue (MEAN)
High Dose RanibizumabTumor Thicknessbaseline4.85 millimeters (mm)
High Dose RanibizumabTumor Thickness12 month2.68 millimeters (mm)
Standard Dose RanibizumabTumor Thicknessbaseline2.91 millimeters (mm)
Standard Dose RanibizumabTumor Thickness12 month0.79 millimeters (mm)
Secondary

Visual Acuity (LogMar)

Time frame: 12 months

ArmMeasureGroupValue (NUMBER)
High Dose RanibizumabVisual Acuity (LogMar)Patient 052.3 LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 02NA LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 060.1 LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 01NA LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 070 LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 03NA LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 081.3 LogMar
High Dose RanibizumabVisual Acuity (LogMar)Patient 042.3 LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 08NA LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 04NA LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 010.1 LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 020.1 LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 031.21 LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 05NA LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 06NA LogMar
Standard Dose RanibizumabVisual Acuity (LogMar)Patient 07NA LogMar

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026