In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
An interventional, prospective, multicenter, open label, single group assignment cohort study for safety will enroll
a total of 770 consecutive qualified patients with end-stage age-related macular degeneration (i.e., patients indicated for implantation of the telescope implant per the product labeling and presenting none of the contraindications), at up to 50 sites. The objective of the study is to assess the safety of the intraocular telescope as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema leading to a persistent loss of best corrected distance visual acuity (BCDVA) > 2-lines from pre-surgery baseline level. The study will test the null hypothesis that the percentage of patients who experience persistent vision impairing corneal edema is >17% against the alternative that the percentage is ≤ 17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence interval for the observed percentage is ≤ 17%.
Study Population Description
Patients must:
¿ have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined
by fluorescein angiography
¿ have evidence of visually significant cataract (≥ Grade 2)
¿ agree to undergo preoperative training in the use of a trial external telescope to verify:
- at least a five-letter improvement on the ETDRS chart with a trial external telescope
- adequate peripheral vision in the eye not scheduled for surgery
¿ agree to participate in a postoperative visual training/rehabilitation.
Sample Size
The sample size of 770 subjects was calculated under the following assumptions:
Two-sided type I error
= 0.05.
Power of 95%.
Over a five year period from implantation, the true percentage of patients experiencing the primary outcome is 12%.
The proportion of the population that is ¿lost¿ (i.e., dies, does not return for a visit, or is lost to follow-up) is 15% each year.
Kaplan- Meier curves will be calculated to describe the time course of persistent vision ¿impairing corneal edema.
The Greenwood formula will be used to calculate the variance of the five-year event rate.
The minimum number of sites participating in IMT-PAS-01 is 20 and approximately 50 sites are expected to participate.
Data Collection
The clinical parameters to be evaluated in both eyes at study visits are:
1. Best spectacle-corrected
distance acuity, using ETDRS charts
2. Slit lamp examination
3. Fundus examination by indirect ophthalmoscopy
4. Intraocular pressure
5. Adverse events.
Followup Visits and Length of Followup
Subjects will be examined and evaluated according to the following schedule of visits:
