Trial Outcomes & Findings for Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2) (NCT NCT01251978)

NCT ID: NCT01251978

Last Updated: 2016-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-10-19

Participant Flow

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

Participant milestones

Measure	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.	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.
Overall Study STARTED	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	High Dose Ranibizumab n=5 Participants patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3.	Standard Dose Ranibizumab n=3 Participants 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.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: complications were only assessed in the high dose group

Outcome measures

Measure	High Dose Ranibizumab n=5 Participants patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3.	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.
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. vascular occlusion	4 participant	—
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. retinal detachment	1 participant	—
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. persistent sub retinal fluid (srf)	1 participant	—
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. CME	1 participant	—
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. metastatic death	1 participant	—

SECONDARY outcome

Timeframe: baseline and 1 year

Outcome measures

Measure	High Dose Ranibizumab n=5 Participants patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3.	Standard Dose Ranibizumab n=3 Participants 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.
Tumor Thickness baseline	4.85 millimeters (mm) Interval 2.5 to 7.48	2.91 millimeters (mm) Interval 2.5 to 3.5
Tumor Thickness 12 month	2.68 millimeters (mm) no measure of dispersion is available - PI left and there is no data available	0.79 millimeters (mm) no measure of dispersion is available - PI left and there is no data available

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	High Dose Ranibizumab n=5 Participants patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3.	Standard Dose Ranibizumab n=3 Participants 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.
Visual Acuity (LogMar) Patient 05	2.3 LogMar	NA LogMar not applicable for this arm
Visual Acuity (LogMar) Patient 06	0.1 LogMar	NA LogMar not applicable for this arm
Visual Acuity (LogMar) Patient 07	0 LogMar	NA LogMar not applicable for this arm
Visual Acuity (LogMar) Patient 01	NA LogMar not applicable for this arm	0.1 LogMar
Visual Acuity (LogMar) Patient 02	NA LogMar not applicable for this arm	0.1 LogMar
Visual Acuity (LogMar) Patient 03	NA LogMar not applicable for this arm	1.21 LogMar
Visual Acuity (LogMar) Patient 04	2.3 LogMar	NA LogMar not applicable for this arm
Visual Acuity (LogMar) Patient 08	1.3 LogMar	NA LogMar not applicable for this arm

Adverse Events

High Dose Ranibizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Dose Ranibizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leslie Hurst- study coordinator

New England Retina Associates

Phone: 203-288-2020

Email: lhurst@retinamd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place