NCT00515814

Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Retina Implant AG · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

Detailed description

Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DEVICE	Retina implant is surgically placed into subretinal position	Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-08-14
• Last updated: 2011-06-09

Locations

2 sites across 1 country: Germany