This trial is active, not recruiting.

Conditions retinitis pigmentosa, retinal degeneration
Treatment device name: "retina implant model alpha". surgical implantation of medical device into eye
Sponsor Retina Implant AG
Start date December 2009
End date February 2016
Trial size 45 participants
Trial identifier NCT01024803, RI-MC-CT-2009


Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.

Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment

Primary Outcomes

Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
time frame: every 3 months for a period of one year

Secondary Outcomes

Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.
time frame: every 3 months for a period of one year
Patient long term safety and stability of implant function
time frame: every 3 months for a period of one year

Eligibility Criteria

Male or female participants from 18 years up to 78 years old.

Inclusion Criteria: - Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones. - Pseudophakia - Angiography shows retinal vessels adequately perfused, despite pathological RP condition. - Age between 18 and 78 years. - Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation. - Ability to read normal print in earlier life, optically corrected without magnifying glass. - Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2. Exclusion Criteria: - Period of appropriate visual functions approx. 12 years / lifetime. - Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant. - Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT). - Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP). - Heavy clumped pigmentation at posterior pole - Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment). - Amblyopia reported earlier in life on eye to be implanted - Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases). - Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression). - Hyperthyroidism or hypersensitivity to iodine - 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 interventional clinical trial within the past 30 days.

Additional Information

Official title Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases
Principal investigator Karl-Ulrich Bartz-Schmidt, Prof. MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Retina Implant AG.