Clinical Policy Bulletin: Suprachoroidal Injection of Pharmacologic Agents
Aetna considers suprachoroidal injection of pharmacologic agents experimental and investigational for all indications because the effectiveness of this approach has not been established.
Treatment of diseases of the posterior segment of the eye such as choroidal neovascularization presents a major challenge in ophthalmology. The posterior segment of the eye, including the retina, macula, and optic nerve, is difficult to access due to the recessed location within the orbital cavity.
Current drug delivery techniques to access the posterior segment of the eye include intra-vitreal injections, peri-ocular injections (i.e., subconjunctival, subtenon, or juxtascleral), and intra-vitreal implants. Drug delivery by injection into the suprachoroidal space is another technique that has recently been proposed in the treatment of posterior segment disease. The suprachoroidal space provides a potential route of access from the anterior region of the eye to the posterior region.
The iScience Surgical Ophthalmic Microcannula, or iTrack (iScience Surgical Corporation, Menlo Park, CA) is designed to access ocular structures such as schlemm's canal, subretinal space, vitreous cavity, and the suprachoroidal space. The iTrack received 510(k) clearance from the U.S. Food and Drug Administration on June 22, 2004 as a flexible microcannual for atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
There is inadequate evidence regarding the clinical utility of supracoroidal injection of pharmacologic agents for the treatment of any ophthalmologic condition. Clinical outcome studies published in the peer-reviewed medical literature are needed to determine the value of this drug delivery method in the management of patients with diseases of the posterior segment of the eye.
In a pilot study, Rizzo et al (2012) evaluated the safety, feasibility, and preliminary effectiveness of suprachoroidal drug delivery with a microcatheter for the treatment of severe subfoveal hard exudates (SHE) in retinal vasculopathies. A total of 6 eyes of 6 patients with central or branch retinal vein occlusion or diffuse diabetic macular edema accompanied by massive refractory SHE underwent a single treatment with bevacizumab and triamcinolone administered to the submacular suprachoroidal space via a microcatheter introduced at the pars plana and advanced posteriorly. The main outcome measures included best-corrected visual acuity, vascular leakage, macular thickness, extent of SHE, and complications. Mean follow-up was 12 months; 3 eyes had central retinal vein occlusion, 1 had branch retinal vein occlusion, and 2 had chronic diabetic macular edema. Best-corrected visual acuity improved by greater than or equal to 2 lines in 4 eyes and remained stable in 2 eyes. At 1 month to 2 months post-procedure, SHE was almost completely resolved in all eyes and macular edema was significantly reduced. There were no surgical or post-operative complications. The authors concluded that suprachoroidal infusion of drugs can be effective in reabsorbing massive SHE. The findings of this pilot study needs to be validated by well-designed studies.
Tetz et al (2012) examined the safety and feasibility of using a microcatheter for drug delivery in the suprachoroidal space in eyes with advanced, exudative, age-related macular degeneration (ARMD) unresponsive to conventional therapy. A unique microcatheter was used to deliver a drug combination consisting of bevacizumab and triamcinolone to the submacular suprachoroidal space. A total of 21 eyes of 21 patients with choroidal neovascularization (CNV) secondary to advanced, exudative ARMD were followed over a 6-month post-procedure period. The microcatheter was successfully and atraumatically inserted into the suprachoroidal space of all eyes. No serious intra-operative or postoperative complications including suprachoroidal hemorrhages were encountered. Post-surgically, complications consisted of 1 eye experiencing a transient elevation in intra-ocular pressure at 3 months, which was medically controlled, and 2 eyes (10.5 %) with an apparent increase in nuclear sclerotic cataracts. The authors concluded that suprachoroidal drug administration was achieved without serious complication using a novel microcatheter. They noted that direct drug delivery to the choroid can potentially increase local tissue drug levels and drug effectiveness for the treatment of ARMD and other diseases associated with CNV. These preliminary findings need to be validated by further studies.
CPT Codes / HCPCS Codes / ICD-9 Codes
Suprachoroidal delivery of pharmacologic agents:
No specific code
The above policy is based on the following references:
Olsen T. Drug delivery to the suprachoroidal space shows promise. Retina Today. 2007;March/April:36-39.
Olsen TW, Feng X, Wabner K, et al. Cannulation of the suprachoroidal space: A novel drug delivery methodology to the posterior segment. Am J Ophthalmol. 2006;142(5):777-787.
U.S. Food and Drug Administration (FDA). iScience surgical ophthalmic microcannula. 510(k) Summary. K041108. iScience Surgical Corporation, Redwood City, CA. Rockville, MD: FDA; June 22, 2004. Available at: http://www.fda.gov/cdrh/pdf4/k041108.pdf. Accessed January 8, 2008.
iScience Interventional. iTrackTM Microcatheter. iScience InterventionalTM. Menlo Park, CA. Available at: http://www.iscienceinterventional.com/US/itrack.htm. Accessed January 8, 2008.
Patel SR, Lin AS, Edelhauser HF, Prausnitz MR. Suprachoroidal drug delivery to the back of the eye using hollow microneedles. Pharm Res. 2011;28(1):166-176.
Rizzo S, Ebert FG, Bartolo ED, et al. Suprachoroidal drug infusion for the treatment of severe subfoveal hard exudates. Retina. 2012;32(4):776-84.
Tetz M, Rizzo S, Augustin AJ. Safety of submacular suprachoroidal drug administration via a microcatheter: Retrospective analysis of European treatment results. Ophthalmologica. 2012;227(4):183-189.
Abarca EM, Salmon JH, Gilger BC. Effect of choroidal perfusion on ocular tissue distribution after intravitreal or suprachoroidal injection in an arterially perfused ex vivo pig eye model. J Ocul Pharmacol Ther. 2013;29(8):715-722.
Kadam RS, Williams J, Tyagi P, et al. Suprachoroidal delivery in a rabbit ex vivo eye model: Influence of drug properties, regional differences in delivery, and comparison with intravitreal and intracameral routes. Mol Vis. 2013;19:1198-1210.
Gilger BC, Abarca EM, Salmon JH, Patel S. Treatment of acute posterior uveitis in a porcine model by injection of triamcinolone acetonide into the suprachoroidal space using microneedles. Invest Ophthalmol Vis Sci. 2013;54(4):2483-2492.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.