Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680225
Other study ID # FVF4290s
Secondary ID
Status Completed
Phase Phase 3
First received May 15, 2008
Last updated April 10, 2017
Start date September 2007
Est. completion date July 2012

Study information

Verified date April 2017
Source New England Retina Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.


Other known NCT identifiers
  • NCT00541528

Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Age > 18 yo.

- Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height.

- Location of the tumor posterior to the equator.

- Documented growth by A/B scan.

- Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc)

- Ability to provide inform consent.

- Comply with the study assessment for the cooperation of the study.

Exclusion Criteria:

- Pregnancy or lactation.

- Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch.

- Current infection or inflammation in either eye.

- Extension of tumor into the orbit.

- Retinal 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ranibizumab injection and TTT - ICG based
Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.

Locations

Country Name City State
United States New England Retina Associates Hamden Connecticut

Sponsors (1)

Lead Sponsor Collaborator
New England Retina Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Tumor Thickness 12 mo
Secondary Visual Acuity Changes 12 mo
See also
  Status Clinical Trial Phase
Completed NCT00750399 - Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma Phase 1
Recruiting NCT03941379 - A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Completed NCT02875652 - Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) N/A
Completed NCT00765921 - Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma Phase 1
Completed NCT00351728 - Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone N/A
Completed NCT01460810 - Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma N/A
Completed NCT01251978 - Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2) Phase 2
Completed NCT00344799 - Cytogenetic Study of Ocular Melanoma
Completed NCT01253759 - Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma Phase 4
Completed NCT03052127 - Study in Subjects With Small Primary Choroidal Melanoma Phase 1/Phase 2
Active, not recruiting NCT00111046 - Pain Relief - Tramadol Versus Ibuprofen Phase 1/Phase 2
Recruiting NCT06007690 - A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma Phase 3
Active, not recruiting NCT04417530 - Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Phase 2
Terminated NCT05266430 - Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)