NCT00999284: Ophthalmologic Examinations After Infusion of ZK200775

Summary

ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail. In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).

Timeline

Start: 1996-12
Primary completion: 1998-04
Completion: 1998-04

Publications

Bergholz R, Staks T, Ruther K. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial. PLoS One. 2010 Aug 12;5(8):e12111. doi: 10.1371/journal.pone.0012111.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	FANAPANEL	Small molecule	0.3 mg/kg	Intravenous
Comparator	FANAPANEL	Small molecule	0.75 mg/kg	Intravenous

Indications

No indication recorded.