Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Phase 2

Terminated

• Conditions: Cystoid Macular Edema; Uveal Melanoma; Radiation Retinopathy; Macular Edema; Radiation Maculopathy
• Interventions: Drug: Ozurdex; Drug: Bevacizumab

• Registration Number: NCT01471054
• Lead Sponsor: Arman Mashayekhi

Brief Summary

To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema after plaque radiotherapy of uveal melanoma.

Detailed Description

Plaque radiotherapy is a commonly used method for treatment of small and medium-sized uveal melanomas. Macular edema is one of the most common causes of visual loss after plaque radiotherapy and has been reported in up to 70% of patients with posterior uveal melanoma. Different methods have been proposed for treatment of post-radiation macular edema and include periocular steroid, intravitreal steroid, intravitreal vascular endothelial growth factor (VEGF) inhibitors, photodynamic therapy, and macular laser photocoagulation.

Injection of intravitreal triamcinolone (a form of steroid) has been found to be useful for treatment of different forms of macular edema but is associated with considerable rates of increased intraocular pressure (glaucoma). Dexamethasone is more potent than triamcinolone and can be safely injected directly into the vitreous cavity (intravitreal injection) but unfortunately its use in the form of intravitreal injection is not practical due to the short half-life of intraocular dexamethasone (about 3 hours).

Within the past several years, tiny drug delivery systems have been developed that allow sustained release of minute amounts of steroid into the back part (vitreous cavity) of the eye, when they are implanted into the vitreous cavity. Ozurdex is a biodegradable dexamethasone intravitreal implant that has been shown to be well-tolerated and effective for up to 6 months in reducing vision loss and improving visual outcome in eyes with different types of macular edema including those secondary to diabetic retinopathy and retinal vein occlusion.

In this study the investigators would like to evaluate the safety and effectiveness of Ozurdex (dexamethasone intravitreal implant) for treatment of macular edema developing after plaque radiotherapy of uveal melanoma.

Study Timeline

• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2014-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2017-11-03
• Results First Submitted QC: 2019-01-08
• Results First Posted: 2019-01-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex	Ozurdex	Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, measurement of best-corrected visual acuity (BCVA), complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year after enrolling into the study.
Bevacizumab	Bevacizumab	Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months after implant. Following the 6-month visit, the patients will be examined every 4-8 weeks depending on the status of their macular edema. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants for Whom Study Eye Showed >=2 Lines of Improvement in Best-corrected Visual Acuity	At 12 months	The number of participants that developed 2 or more lines of visual acuity improvement in the study eye. Visual acuity was measured with Snellen eye chart placed 10 feet away from the patient.

Secondary Outcome Measures

Name	Time	Method
Development of Retinal Detachment	At 12 months	Development of rhegmatogenous retinal detachment in the study eye.
Change in Central Subfield Retinal Thickness	At 12 months	Increase or decrease in central subfield retinal thickness in microns based on spectral-domain optical coherence tomography measurement
Development of Glaucoma	At 12 months	Intraocular pressure more than 21 mm Hg as measured with applanation tonometry.
Development of Cataract	At 12 months	Development of visually-significant lens opacity based on judgement of examining physician.
Development of Vitreous Hemorrhage	At 12 months	Development of hemorrhage in the vitreous cavity detectable with slit lamp examination or dilated funduscopy.

Trial Locations

Locations (1)

Ocular Oncology Service, Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States