Treatment Of Radiation Retinopathy Trial

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Brief Title

Treatment Of Radiation Retinopathy Trial

Official Title

Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.

Brief Summary

      The purpose of this study is to demonstrate a statistically significant improvement of visual
      acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in
      patients with radiation retinopathy.
    

Detailed Description

      Approximately 30-40% of patients develop a deterioration of visual acuity within 5 years
      after treatment of uveal melanoma using radiation therapy and TTT due to radiation
      retinopathy (Shields 2002, Bartlema 2003). By administration of either Lucentis® or
      Triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a
      statistically significant improvement in visual acuity and a reduced amount of macular edema
      and vascular leakage. Additionally, we hope to obtain a better understanding of the
      pathophysiologic processes involved, by demonstrating a possible relation between high levels
      of angiogenic factors (VEGF) in the anterior chamber fluid, and radiation retinopathy. In
      conclusion, we hope to provide evidence for a new therapy in patients with retinopathy, due
      to radiation in uveal melanoma. There is no scientifically proven treatment available at this
      time.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA)

Secondary Outcome

 To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.

Condition

Uveal Melanoma

Intervention

ranibizumab

Study Arms / Comparison Groups

 1: Lucentis
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

220

Start Date

September 2009


Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  The eye was previously irradiated for treatment of a uveal melanoma;

          -  Decrease of visual acuity after irradiation therapy by more than 10 letters (ETDRS)
             and is now 20/40 or less;

          -  Vision decrease is considered to be due to central radiation retinopathy with
             significant macular edema or optic disc edema;

          -  Age 18 years or older;

          -  The patient is fully competent;

          -  Written informed consent to participate in the trial is given.

          -  Patient is not pregnant (or not fertile) and is willing to use contraceptives for the
             duration of the trial (one year)

          -  Patient is willing and able to return for follow-up.

        Exclusion Criteria:

          -  Vision decrease is considered to be due to ischemic radiation retinopathy without
             macular edema or optic disc edema;

          -  Other, approved therapy indicated for treatment of condition;

          -  Presence of metastasis;

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the patient to participate in the trial;

          -  Pre-existing retinopathy due to other disorders;
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martine J Jager, MD, PhD, +31715263097, [email protected]



Administrative Informations


NCT ID

NCT00811200

Organization ID

P09.



Study Sponsor

Leiden University Medical Center

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Martine J Jager, MD, PhD, Principal Investigator, Leiden University Medical Center


Verification Date

June 2009