Clinical trial · Interventional
Treatment Of Radiation Retinopathy Trial
Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
NCT00811200CI-TRIAL-00002424TORRunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ranibizumab | Drug | — | UNRESOLVED |
| sham | Other | — | UNRESOLVED |
| triamcinolone acetonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1: Lucentis
- interventionNames
- Drug: ranibizumab
- type
- ACTIVE_COMPARATOR
- label
- 2: Kenalog
- interventionNames
- Drug: triamcinolone acetonide
- type
- SHAM_COMPARATOR
- label
- 3: No treatment
- interventionNames
- Other: sham
Primary outcomes (1)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.