Treatment Of Radiation Retinopathy Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment Of Radiation Retinopathy Trial

Official Title ^†

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 II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]
To evaluate the effects of ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) on central retinal thickness, severity of retinopathy and other anatomical changes relative to no treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
To demonstrate a possible relation between decreasing levels of angiogenic factors (such as VEGF) in the anterior chamber fluid and a good response to treatment with ranibizumab or triamcinolone acetonide, and radiation retinopathy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Condition ^†

Uveal Melanoma

Intervention ^†

Drug: ranibizumab
Drug: triamcinolone acetonide
Other: sham

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Enrolling by invitation

Enrollment ^†

220

Start Date ^†

February 2008

Completion Date

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00811200

Organization ID

P07.070

Secondary IDs ^††

Study Sponsor ^†

Leiden University Medical Center

Collaborators ^††

Novartis Pharmaceuticals

Investigators ^†

Principal Investigator:

Martine J Jager, MD, PhD

Leiden University Medical Center

Information Provided By

Leiden University Medical Center

Verification Date

December 2008

First Received Date ^†

December 17, 2008

Last Updated Date

December 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.