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

NCT00515814 | Completed DMC

• 2 other identifiers: RI-PT-2005Retina Implant Project
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Retinitis Pigmentosa

Keywords

Legal blindness; Retinopathy pigmentosa; Hereditary condition; Photo-receptor degeneration; Retina implant; Subretinal implant

Outcome Measures

Primary Outcomes (2)

• Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)

  within implantation period

• Patient treatment shows acceptable results (i.e. SAFETY)

  within implantation period

Secondary Outcomes (2)

• Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)

  within implantation period

• Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)

  within implantation period

Study Arms (1)

1, 2

EXPERIMENTAL

During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Device: Retina implant is surgically placed into subretinal position

Interventions

Retina implant is surgically placed into subretinal position DEVICE

Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.

Also known as: Retina Implant, subretinal implant, vision prosthesis,, medical device for restoration of vision

1, 2

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
• Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
• Period of appropriate visual functions \> 12 years / lifetime
• Visual acuity ≥ 0,05 in earlier life
• Electrically Evoked Phosphenes provide evidence of inner-retinal function.
• willing and able to give written informed consent

You may not qualify if:

• Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
• Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
• Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
• Retina detected as too thin (\< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
• Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study
• Participation in another clinical trial within the past 30 days

Sponsors & Collaborators

• Retina Implant AG: lead

Study Sites (2)

Eye Hospital Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

University Eye Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.

  PMID: 24150759 DERIVED

• Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.

  PMID: 22562517 DERIVED

• Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. doi: 10.1167/iovs.10-6946.

  PMID: 21693599 DERIVED

Related Links

• patient self-help, support and advocacy organization

MeSH Terms

Conditions

Retinitis Pigmentosa; Blindness

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eberhart - Zrenner, Prof.Dr.med.

  University Eye Hospital Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

DE (2)