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


Phase 2
50 Years
90 Years
Not Enrolling
Both
Choroidal Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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 using the incidence and severity of adverse events.

Outcome Description:

We are going to evaluate if the patients develop adverse events such as: Branch retinal vein occlusions, decreased visual acuity or cystoid macular edema. It is important to determine the local control of the tumor.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Peter E Liggett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New England Retina Associates

Authority:

United States: Food and Drug Administration

Study ID:

FVF4927s

NCT ID:

NCT01251978

Start Date:

July 2010

Completion Date:

August 2012

Related Keywords:

  • Choroidal Melanoma
  • Choroidal melanoma
  • Ranibizumab
  • Transpupillary Thermotherapy
  • CSTIP
  • Indocyanine Green
  • Melanoma

Name

Location
New England Retina Associates Hamden, Connecticut  06518