## Protocol Section
### Identification Module
**NCT ID:** NCT01497379

**Brief Title:** Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

**Official Title:** Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.

#### Organization Study ID Info
**ID:** HKCTR-1198
#### Organization
**Class:** INDUSTRY
**Full Name:** Retina Implant AG
#### Secondary ID Infos
**Domain:** Clinicaltrials.gov
**ID:** RI-MC-CT-2009
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2015-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-29

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Start Date
**Date:** 2011-10

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2011-12-22
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-15
**Study First Submit QC Date:** 2011-12-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Retina Implant AG

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.

### Conditions Module

**Conditions:**

- Retinal Degeneration

- Retinitis Pigmentosa

**Keywords:**

- Hereditary retinal

- degeneration outer

- retinal layers

- photoreceptor rods cones

- Retinitis pigmentosa

- blindness

- reading ability

- retina implant

- subretinal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** intra-individual implant activation

**Intervention Names:**

- Procedure: surgical implantation of subretinal device

**Label:** intra-individual implant ON

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** intra-individual implant deactivation

**Intervention Names:**

- Procedure: surgical implantation of subretinal device

**Label:** intra-individual implant OFF

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intra-individual implant ON

**Description:** surgical implantation of subretinal device

**Name:** surgical implantation of subretinal device

**Other Names:**

- Retinal implant, subretinal implant

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- intra-individual implant OFF

**Description:** intra-individual implant OFF

**Name:** surgical implantation of subretinal device

**Other Names:**

- Retinal implant, subretinal implant

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients

**Measure:** Safety

**Time Frame:** 1 year

**Description:** Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests:

* Activities of Daily Living tasks or
* Recognition tasks or
* Mobility or
* a combination of the above

**Measure:** Efficacy

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Patient long term safety:

* stability of implant function
* stability of body structure \& function related to implant system

**Measure:** Safety

**Time Frame:** 1 year

**Description:** Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via:

* FrACT or
* BaLM or
* Grating test (e.g. BaGA) and/or Quality of life
* Quality of life (questionnaire) or
* a combination of the above

**Measure:** Efficacy

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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 (impaired light localization or worse).
* 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

Exclusion Criteria:

* Period of appropriate visual functions \< 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.

**Maximum Age:** 78 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Ophthalmology Eye Institute, University of Hong Kong

**State:** Cyberport

**Zip:** 100

#### Overall Officials

**Official 1:**

**Affiliation:** Chair Professor in Ophthalmology Eye Institute

**Name:** David Wong, Prof., MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.

**PMID:** 25812924

#### See Also Links

**Label:** Hong Kong clinical trials registry

**URL:** http://www.hkclinicaltrials.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000058499

- Term: Retinal Dystrophies

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5047

- Name: Blindness

- Relevance: LOW

- As Found: Unknown

- ID: M15008

- Name: Retinitis

- Relevance: HIGH

- As Found: Retinitis

- ID: M15009

- Name: Retinitis Pigmentosa

- Relevance: HIGH

- As Found: Retinitis Pigmentosa

- ID: M14997

- Name: Retinal Degeneration

- Relevance: HIGH

- As Found: Retinal Degeneration

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M29107

- Name: Retinal Dystrophies

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T4945

- Name: Retinitis Pigmentosa

- Relevance: HIGH

- As Found: Retinitis Pigmentosa

### Condition Browse Module - Meshes

- ID: D000012173

- Term: Retinitis

- ID: D000012174

- Term: Retinitis Pigmentosa

- ID: D000012162

- Term: Retinal Degeneration

### Misc Info Module

- Version Holder: 2024-05-24
