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Treatment Of Radiation Retinopathy Trial (TORR)

Primary Purpose

Uveal Melanoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ranibizumab

triamcinolone acetonide

sham

About this trial

This is an interventional treatment trial for Uveal Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

1: Lucentis

2: Kenalog

3: No treatment

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.

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

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

Full Information

NCT ID

NCT00811200

First Posted

December 17, 2008

Last Updated

June 30, 2009

Sponsor

Leiden University Medical Center

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00811200

Brief Title

Treatment Of Radiation Retinopathy Trial

Acronym

TORR

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Leiden University Medical Center

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveal Melanoma

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1: Lucentis

Arm Type

Active Comparator

Arm Title

2: Kenalog

Arm Type

Active Comparator

Arm Title

3: No treatment

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Intervention Description

three initial monthly intra vitreal injections with 0.5 mg ranibizumab

Intervention Type

Drug

Intervention Name(s)

triamcinolone acetonide

Intervention Description

at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide

Intervention Type

Other

Intervention Name(s)

sham

Intervention Description

at baseline one sham-injection

Primary Outcome Measure Information:

Title

Time Frame

one year

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martine J Jager, MD, PhD

Phone

+31715263097

m.j.jager@lumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martine J Jager, MD, PhD

Organizational Affiliation

Leiden University Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Treatment Of Radiation Retinopathy Trial

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