Treatment Of Radiation Retinopathy Trial
TORR
1 other identifier
interventional
220
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedJuly 2, 2009
June 1, 2009
2.3 years
December 17, 2008
June 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.
one year
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
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
Study Arms (3)
1: Lucentis
ACTIVE COMPARATOR2: Kenalog
ACTIVE COMPARATOR3: No treatment
SHAM COMPARATORInterventions
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Novartis Pharmaceuticalscollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine J Jager, MD, PhD
Leiden University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
September 1, 2009
Primary Completion
January 1, 2012
Last Updated
July 2, 2009
Record last verified: 2009-06