Status:
UNKNOWN
Treatment Of Radiation Retinopathy Trial
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
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, B...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00811200
Start Date
September 1 2009
Last Update
July 2 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.