A meeting of the Ophthalmic Devices Panel was held on March 27, 2009. The Panel discussed the submission, made several specific recommendations, and voted on the premarket approval application (P050034) for theVisionCare Technologies, Inc. IMT™ Implantable Miniature Telescope.
Vision Care's Implantable Miniature Telescope (IMT) is a visual prosthetic device which, when combined with the cornea, constitutes a telephoto lens for improvement of visual acuity in patients with bilateral moderate to profound visual loss secondary to end-stage macular degeneration. The IMT device is surgically implanted in the posterior chamber of the eye, in place of the eye's crystalline lens and is held in position by haptic loops. The IMT is available in two models: Wide Angle 2.2X and Wide Angle 3X, which provide nominal magnification of 2.2x and 2.7x, respectively.
The Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) is indicated to improve vision by monocular implantation in patients 65 or older with stable moderate (distance BCVA of ≤ 20/80) to profound (distance BCVA ≥ 20/800) vision impairment caused by bilateral central scotomoas associated with end-stage age-related macular degeneration. Patients must have:
- retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography,
- evidence of cataract,
- at least a five-letter improvement on the ETDRS chart with an external telescope,
- adequate peripheral vision in the eye not scheduled for surgery
- willingness to participate in a postoperative visual training/rehabilitation program.
The sponsor presented data from their PMA from two protocols conducted under the same IDE. The first is protocol IMT-002, the primary clinical trial. The second protocol, IMT-002-LTM is for the long term follow-up of subjects enrolled in protocol IMT-002. The details of these protocols are described below.
In protocol IMT-002 the sponsor conducted a prospective multi-center clinical trial utilizing twenty-eight (28) clinical sites and enrolling a total of 218 consecutive subjects.
In protocol IMT-002-LTM, one hundred twenty-nine of the original subjects were enrolled to provide an additional 36 months of safety data.
Following presentations by the sponsor and the FDA, and after extensive deliberation, the Panel voted unanimously in favor of “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
1) Development of an informed consent procedure to communicate the risks to the patient.
2) Conduct of 2 post approval studies:
- Follow-up of the current cohort for a total of 7-10 years;
- New patient cohort to address use in the "real world."
3) Rates of risks for adverse events should be calculated utilizing survival analysis and communicated in labeling for patients and physicians.
Contact: Deborah Falls, Project Manager
(240) 276-4200, Deborah.Falls@fda.hhs.gov
James Swink, Executive Secretary,
(240) 276-4050 James.Swink@fda.hhs.gov
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