Treatment Of Radiation Retinopathy Trial

Uveal Melanoma Clinical Trial

— TORR  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00811200
• Other study ID #: P09.
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 17, 2008
• Last updated: June 30, 2009
• Start date: September 2009

Study information

• Verified date: June 2009
• Source: Leiden University Medical Center
• Contact: Martine J Jager, MD, PhD
• Phone: +31715263097
• Email: m.j.jager[@]lumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Retinal Diseases
• Uveal Melanoma

Intervention

Drug:
• ranibizumab
three initial monthly intra vitreal injections with 0.5 mg ranibizumab
• triamcinolone acetonide
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

Other:
• sham
at baseline one sham-injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.		one year	No
Secondary	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	No
Secondary	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	No