Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01251978|
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Choroidal Melanoma||Drug: Ranibizumab 2 mg Drug: 0.5 mg Ranibizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: High dose Ranibizumab
6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Drug: Ranibizumab 2 mg
intravitreal injections of ranibizumab once a month, times 3.
Active Comparator: Standard Dose Ranibizumab
6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
Drug: 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. [ Time Frame: 1 year ]
- Tumor Thickness [ Time Frame: baseline and 1 year ]
- Visual Acuity (LogMar) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251978
|United States, Connecticut|
|New England Retina Associates|
|Hamden, Connecticut, United States, 06518|
|Principal Investigator:||Peter E Liggett, MD||New England Retina Associates|