Treatment Of Radiation Retinopathy Trial

NCT ID: NCT00811200

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30

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.

Conditions

Uveal Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1: Lucentis

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

2: Kenalog

Group Type: ACTIVE_COMPARATOR

triamcinolone acetonide

Intervention Type: DRUG

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

3: No treatment

Group Type: SHAM_COMPARATOR

sham

Intervention Type: OTHER

at baseline one sham-injection

Interventions

ranibizumab

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

Intervention Type: DRUG

triamcinolone acetonide

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

Intervention Type: DRUG

sham

at baseline one sham-injection

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Leiden University Medical Center

Principal Investigators

Martine J Jager, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Central Contacts

Martine J Jager, MD, PhD

Role: CONTACT

m.j.jager@lumc.nl

+31715263097

Other Identifiers

P09.

Identifier Type: -

Identifier Source: org_study_id