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Treatment Of Radiation Retinopathy Trial

Information source: Leiden University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uveal Melanoma

Intervention: ranibizumab (Drug); triamcinolone acetonide (Drug); sham (Other)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Leiden University Medical Center

Official(s) and/or principal investigator(s):
Martine J Jager, MD, PhD, Principal Investigator, Affiliation: Leiden University Medical Center

Overall contact:
Martine J Jager, MD, PhD, Phone: +31715263097, Email: m.j.jager@lumc.nl

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: 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)

Secondary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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;

Locations and Contacts

Martine J Jager, MD, PhD, Phone: +31715263097, Email: m.j.jager@lumc.nl

Additional Information

Starting date: September 2009
Last updated: June 30, 2009

Page last updated: August 23, 2015

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