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An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma


Phase 1
21 Years
N/A
Not Enrolling
Both
Radiation Retinopathy, Choroidal Melanoma

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Trial Information

An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma


Following plaque brachytherapy as treatment for choroidal melanoma, patients may develop
radiation retinopathy. Radiation retinopathy is a progressive condition that leads to
blindness in over 50% of cases within 5 years of treatment.

Vascular endothelial growth factor (VEGF) protein is believed to play a critical role in
angiogenesis and radiation retinopathy. It is one of the key contributors to physiological
or pathological conditions that can stimulate both the formation of new blood vessels and
normal vessel incompetence. Ranibizumab is a recently approved vascular endothelial growth
factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration.
Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has
been shown to cause neovascularization and leakage in models of ocular angiogenesis.

This is an open label, non-randomized active treatment, Phase I trial to assess the safety
and tolerability of intravitreal ranibizumab and its ability to reduce radiation retinopathy
and potentially limit vision loss associated with this disease.


Inclusion Criteria:



- Diagnosis of radiation retinopathy

- History of choroidal melanoma status post plaque brachytherapy

- Age > 21 years

- Ability to perform written consent and comply with study assessments for the full
duration of the study

Exclusion Criteria:

- Pregnancy or lactation, pre-menopausal women not using contraception

- Participation in another simultaneous medical investigation or trial

- Patient with significantly compromised visual acuity in the study eye due to
concomitant ocular conditions.

- Patients who have undergone intraocular surgery within last 60 days.

- Patients who have had intravitreal anti-VEGF treatment within 45 days.

- Patients who have had intravitreal triamcinolone acetonide within 4 months.

- Patients who have had laser within 60 days.

- Inability to obtain photographs to document CNV (including difficulty with venous
access).

- Patient has a history of any medical condition which would preclude scheduled visits
or completion of study.

- Aphakia or absence of the posterior capsule in the study eye. Previous violation of
the posterior capsule in the study eye is also excluded unless as a result of yttrium
aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber
lens implantation..

- History of glaucoma filtering surgery in the study eye.

- Concurrent use of more than two therapies for glaucoma.

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Paul T Finger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The New York Eye Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

FVF4519s

NCT ID:

NCT00750399

Start Date:

October 2008

Completion Date:

September 2011

Related Keywords:

  • Radiation Retinopathy
  • Choroidal Melanoma
  • radiation
  • retinopathy
  • ranibizumab
  • melanoma
  • choroid
  • Melanoma
  • Retinal Diseases

Name

Location

The New York Eye Cancer CenterNew York, New York  10021