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

Part of paid clinical trials in Hamden, Connecticut.

Sponsor
New England Retina Associates
Study ID
NCT01251978
Phase
PHASE2
Status
Completed

Conditions

  • Choroidal Melanoma

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab 2 mg — DRUG
    intravitreal injections of ranibizumab once a month, times 3.
  • 0.5 mg Ranibizumab — DRUG
    6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.

Study Details

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.

Key Dates

First listed
Dec 2, 2010
Start date
Jul 31, 2010
Status verified
Oct 2016
Primary completion
Jul 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: High dose Ranibizumab
    6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
  • Active Comparator: Standard Dose Ranibizumab
    6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
New England Retina AssociatesHamdenConnecticut06518-

Find similar trials in Hamden, CT

By research site
New England Retina Associates· Hamden, CT

Related Studies