Uveal MelanomaPhase 2/3TORRNCT00811200
Treatment Of Radiation Retinopathy Trial
A Phase 2/3 study testing ranibizumab and triamcinolone acetonide in people with Uveal Melanoma, run by Leiden University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- ranibizumab and triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
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.
Read the 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
- Being tested
- ranibizumab, triamcinolone acetonide, sham
- Keywords
- radiation, retinopathy, maculopathy, choroidopathy, uveal, melanoma, lucentis, ranibizumab, kenalog, triamcinolone acetonide, radiation retinopathy after irradiation of uveal melanoma, radiation maculopathy after irradiation of uveal melanoma, radiation choroidopathy after irradiation of uveal melanoma
- Medical subject headings
- Uveal Melanoma, Retinal Diseases, Macular Degeneration, Choroid Diseases, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
three initial monthly intra vitreal injections with 0.5 mg ranibizumab
triamcinolone acetonideDrug
at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
shamOther
at baseline one sham-injection
| Study group | Role | What they receive |
|---|---|---|
| 1: Lucentis | Active comparator | Not described Receives: Drug: ranibizumab |
| 2: Kenalog | Active comparator | Not described Receives: Drug: triamcinolone acetonide |
| 3: No treatment | Sham comparator | Not described Receives: Other: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startSep 2009
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- Martine J Jager, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811200
- Sponsor's protocol ID
- P09.
- Acronym
- TORR
- Status last verified
- Jun 2009
- First submitted
- 17 Dec 2008
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
- ClinicalTrials.gov ID
- NCT00811200
- Acronym / sponsor ID
- TORR / P09.
- Conditions
- Uveal Melanoma
- Keywords
- radiation, retinopathy, maculopathy, choroidopathy, uveal, melanoma, lucentis, ranibizumab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (estimated)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Lucentis | Active comparator | Drug: ranibizumab |
| 2: Kenalog | Active comparator | Drug: triamcinolone acetonide |
| 3: No treatment | Sham comparator | Other: sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabthree initial monthly intra vitreal injections with 0.5 mg ranibizumab | Drug | 1: Lucentis |
| triamcinolone acetonideat baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide | Drug | 2: Kenalog |
| shamat baseline one sham-injection | Other | 3: No treatment |
Primary outcome
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)
Time frame: one year
3 secondary outcomes
To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine J Jager, MD, PhD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ranibizumab and triamcinolone acetonide in people with Uveal Melanoma, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine J Jager, MD, PhD (+31715263097, m.j.jager@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.