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Democritus_of_Abdera

06/25/08 5:57 PM

#1986 RE: DewDiligence #1984

MK0140 = MRK’s code for the I-vation TA implant...

Dew, the Phase IIb clinical trial that you refer to in #msg-30254260 can be accessed using ClinicalTrials.gov identifier NCT00692614 (Merck’s Study ID number is 2008_521, MK0140-001).

Some additional information that can be obtained from the clinicaltrials.gov site include:

1) The study will evaluate the treatment effects of three doses of the I-vation TA implant (MK0140) over a 12 month period.

2) They will measure changes from baseline in OCT retinal thickness and evaluate the safety and tolerability of the three doses after 12 months of therapy. Secondary outcomes will be visual acuity, change from baseline in OCT center-point retinal thickness, the need for focal/grid laser photocoagulation, and progression of diabetic retinopathy. ... Notably, they are not formally evaluating rises in intraocular pressure; albeit they will exclude patients with a history of elevated intraocular pressure in response to ocular steroid therapy in either eye. ... I continue to believe that the risk of glaucoma is the major confounding variable for steroid therapy of retinal disease.

3) They estimate enrollment of 628 volunteers with a primary completion date of June 2010.

OCT refers to optical coherence tomography, a noninvasive imaging technique (see http://www.retinaeyecenter.com/oct.htm ).