Intraocular epiretinal brachytherapy has been proposed as a treatment of exudative age-related macular degeneration (AMD). This procedure utilizes a pen-sized intraocular epiretinal device that delivers strontium-90 radiation directly to the leaking vessels in the retina that affect central vision. Intraocular epiretinal brachytherapy is purported to provide efficient "radioactive surgery" with the benefits of high-dose external beam radiation therapy while avoiding or minimizing the latter's adverse effects on vision loss.

Note: Please see the following related documents for additional information:

• DRUG.00028 Intravitreal and Periocular Injection Treatment for Retinal Vascular Conditions
• RAD.00014 Brachytherapy for Oncologic Indications

Investigational and Not Medically Necessary:

Intraocular epiretinal brachytherapy is considered investigational and not medically necessary as a treatment of exudative age-related macular degeneration (AMD) and for all other indications.

The device used to administer intraocular epiretinal brachytherapy (Epi-Rad90™ Ophthalmic System [NeoVista^®, Inc., Newark, CA] is currently being studied in a Phase III clinical study (Study of Strontium90 Beta Radiation With Lucentis^® to Treat Age-Related Macular Degeneration [CABERNET]). The clinical trial is a prospective randomized controlled study which seeks to gain information regarding the outcomes of individuals treated with Lucentis^® (ranibizumab) alone, or with Lucentis^® in combination with intraocular epiretinal brachytherapy (the Epi-Rad90™ Ophthalmic System procedure). The study began accepting participants in 2007 and will be conducted at approximately 30 sites worldwide with 450 participants in the intraocular epiretinal brachytherapy arm and 150 participants in the Lucentis^® only arm. The study is expected to be completed in 2011.

Peer-reviewed published studies regarding the safety, efficacy or improved outcomes of individuals undergoing intraocular epiretinal brachytherapy for AMD are insufficient in numbers. Avila (2009) reported a study which evaluated the short-term safety and possibility of epiretinal brachytherapy delivered along with intravitreal bevacizumab for the treatment of AMD for 12 months. Thirty-four participants received a single treatment with 24 Gy beta radiation and two injections of bevacizumab. No radiation-associated adverse events were observed 12 months after treatment. At 12 months, 91% of participants lost less than 3 lines of vision, 68% of participants improved or maintained their best corrected visual acuity (BCVA) and 38% of participants gained greater than 3 lines of vision. The safety and efficacy of intraocular epiretinal brachytherapy given along with bevacizumab for the treatment of AMD looks promising. The authors stated that long-term safety will be assessed for 3 years in a large, multicenter phase III study. Further studies are needed prior to drawing conclusions regarding the safety and efficacy of intraocular, epiretinal brachytherapy for AMD.

A recent Cochrane review (Evans, 2010) evaluated the use of radiation therapy for the treatment of AMD. While the incidence of adverse reactions were low, the results of the different trials were inconsistent and the "review currently does not provide convincing evidence that radiotherapy is an effective treatment for neovascular AMD."

At the time of this review, NeoVista^® has not received approval from the U.S. Food and Drug Administration (FDA) to market the Epi-Rad90™ Ophthalmic System in the United States.

AMD is the leading cause of legal blindness in individuals over age 60 in developed nations. AMD is broadly classified into two types: nonexudative (dry) and exudative (wet). Wet AMD arises from abnormal blood vessels behind the retina which start to grow under the macula (the light sensitive part of the retina). These new blood vessels have a tendency to be very fragile and often leak fluid and blood. The blood and fluid cause the macula to move from its normal position at the back of the eye. Loss of central vision (needed for seeing objects clearly and for activities such as reading and driving), can occur rapidly. Dry (nonexudative) AMD occurs when the light-sensitive cells in the macula gradually break down, resulting in blurred central vision in the affected eye. Over time, as less of the macula functions, central vision is gradually lost in the affected eye.

Intraocular brachytherapy employs a pen-sized intraocular epiretinal probe to deliver strontium-90 radiation directly to the leaking vessels in the retina that affect central vision. Intraocular epiretinal brachytherapy is being investigated as a means to provide high-dose radiation therapy while reducing the exposure of radiation to the surrounding tissue.

Age-related macular degeneration (AMD): A slowly progressive, painless disease affecting the macula that blurs the sharp, central vision needed for "straight-ahead" activities such as reading, sewing, and driving.

Brachytherapy (also known as internal radiation): A type of radiation treatment used to stop the growth of cancer cells by implanting radioactive material directly into the tumor or into the surrounding tissues.

Neovascular (Wet) AMD: This is a subset of AMD representing approximately 10% of all cases but accounting for 90% of the severe vision loss. AMD occurs when abnormal blood vessels behind the retina start to grow under the macula. These new blood vessels tend to be very fragile and often leak blood and fluid which thickens the macula and damages the photoreceptors. This damage to the macula can occur rapidly, resulting in a sudden loss of central vision. Wet AMD is considered to be advanced AMD and is more severe than the dry form.

Radiation therapy: Also known as radiotherapy, this technique uses ionizing radiation to deposit energy at targeted tissue to injure or destroy it.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Avila MP, Farah ME, Santos A, et al. Twelve-month short-term safety and visual-acuity results from a multicentre prospective study of epiretinal strontium-90 brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularisation secondary to age-related macular degeneration. Br J Ophthalmol. 2009; 93(3):305-309.
2. Friedman DS, O'Colmain BJ, Muñoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004; 122(4):564-572.
3. Jaakkola A, Heikkonen J, Tommila P, et al. Strontium plaque brachytherapy for exudative age-related macular degeneration: three-year results of a randomized study. Ophthalmology. 2005; 112(4):567-573.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. Evans JR, Sivagnanavel V, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database of Syst Rev. 2010; (5):CD004004.
2. NeoVista. A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration (CABERNET). NLM Identifier: NCT00454389. Last updated on October 28, 2009. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00454389?term=CABERNET&rank=1 Accessed on January 28, 2011.

1. National Eye Institute. Age-Related Macular Degeneration. Available at: http://www.nei.nih.gov/health/maculardegen/armd_facts.asp Accessed on January 28, 2011.

Epi-Rad90™ Ophthalmic System
Intraocular Epiretinal Brachytherapy

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