Treatment Of Radiation Retinopathy Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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;