Treatment Of Radiation Retinopathy Trial (TORR)

Leiden University Medical Center (LUMC)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Uveal Melanoma

Treatments: Other: sham; Drug: triamcinolone acetonide; Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00811200

P09.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 3 patient groups

1: Lucentis

Active Comparator group

Treatment:

Drug: ranibizumab

2: Kenalog

Active Comparator group

Treatment:

Drug: triamcinolone acetonide

3: No treatment

Sham Comparator group

Treatment:

Other: sham