TORR: Treatment Of Radiation Retinopathy Trial

Sponsor

Leiden University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00811200

Collaborator

Novartis Pharmaceuticals (Industry)

220

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Drug: ranibizumab Drug: triamcinolone acetonide Other: sham	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1: Lucentis	Drug: ranibizumab three initial monthly intra vitreal injections with 0.5 mg ranibizumab
Active Comparator: 2: Kenalog	Drug: triamcinolone acetonide at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
Sham Comparator: 3: No treatment	Other: sham at baseline one sham-injection

Arm

Intervention/Treatment

Active Comparator: 1: Lucentis

Drug: ranibizumab

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

Active Comparator: 2: Kenalog

Drug: triamcinolone acetonide

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

Sham Comparator: 3: No treatment

Other: sham

at baseline one sham-injection

Outcome Measures

Primary Outcome Measures

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) [one year]

Secondary Outcome Measures

To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment. [one year]
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 [one year]
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 [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;