Retinitis Pigmentosa.Phase 2NCT00345917
Safety Study in Retinal Transplantation for Retinitis Pigmentosa.
A Phase 2 study testing Retinal transplantation instrument and Fetal tissue. in people with Retinitis Pigmentosa., run by Radtke, Norman D., M.D. at 1 site in United States.
Trial summary
The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Retinitis Pigmentosa.
- What is being tested?
- Retinal transplantation instrument and Fetal tissue.
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must have decreased central visual acuity of 20/200 or worse in one eye by ETDRS vision testing for a duration of at least one year in the operated eye and have the diagnosis of retinitis pigmentosa; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200.
- Subject is older than 21 years of age
- Patient is willing to return for follow-up visits
- Patient has signed informed consent for retinal transplantation
- Patient has undergone microperimetry and Goldmann visual field testing.
Who cannot join
- Patient having a central visual acuity of better than 20/200 in one eye by ETDRS or vision worse than 20/200 in one eye by ETDRS for a duration of less than one year
- Unwilling to sign an informed consent
- Patient under 21 years of age
- Patient having medical problems that are contraindicatory for short-term anesthesia
- Patient unwilling to return for follow-up visits
- The patient has been determined to be pregnant by patient history or by pregnancy testing in women of childbearing potential
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- A tear of the retinal pigment epithelium
- Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome
- Inability to obtain photographs to document fundus condition, including difficulty with venous access
- Participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment
- Intraocular surgery within the last two months or capsulotomy within the last month in the study eye
- Patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Vitreous Resource Center
Louisville, Kentucky, 40217
About this study
The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.
Read the detailed description
The aim of this clinical trial is to test the safety of transplanting human fetal neural retinal tissue and retinal pigment epithelium into the eyes of human patients with retinitis pigmentosa. Vision in the eye to be operated on will be the poorer vision of both eyes and must be 20/200 or worse. "Retinal tissue", the layers in the back of the eye, consists of neural retina and retinal pigment epithelium. "Neural retina" is the nerve cell layer that processes light into vision. The "photoreceptor cells" in the neural retina detect the light and transform it into electrical signals, which are then transferred to the brain by other retinal cells. "Retinal pigment epithelium" (RPE) is the layer behind the neural retina which helps both to nourish the cells of the neural retina and also to get rid of waste products. The fetal tissues used in this study will be derived from dead fetuses in the first 9-16 weeks of pregnancy obtained from elective abortions.
Fetal retinal transplantation is highly experimental. The research will be conducted in accordance with the prohibitions regarding the use of human fetal tissue described in Public Law 103-43, section 498B. There will be no compensation for the donor. The research will be conducted in accordance with any applicable Federal, State and local laws.
First, the technical application of the implantation instrument and its safety in the transplantation will be demonstrated in patients with 20/200 vision in one eye or worse, with functional acuity in the contra lateral eye.
Secondly, the human fetal retinal tissue will be placed in the areas beneath the retina where presently the patient has atrophy of the retinal pigment epithelium and poor retinal function.
- Conditions
- Retinitis Pigmentosa.
- Being tested
- Retinal transplantation instrument, Fetal tissue.
- Keywords
- Retinitis Pigmentosa, Retinal Transplant, Fetal Tissue, Early treatment diabetic retinopathy study, 20/200 or worse.
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal transplantation instrumentDevice
Fetal tissue.Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Snellen
Visual acuity
Microperimetry
Goldmann visual field
Optical coherent tomography
Fluorescein angiography
Secondary outcomes (1)
No rejection of transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startFeb 2002
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinitis Pigmentosa.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radtke, Norman D., M.D.
- Collaborators
- Foundation Fighting Blindness
- Responsible party
- Sponsor
- Investigators
- Norman D. Radtke, M.D., Principal investigator, Norman D. Radtke, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345917
- Sponsor's protocol ID
- 20050137
- Status last verified
- Apr 2012
- First submitted
- 28 Jun 2006
- Last updated
- 11 Apr 2012
- Results posted
- No
Publications
Radtke ND, Aramant RB, Seiler MJ, Petry HM, Pidwell D. Vision change after sheet transplant of fetal retina with retinal pigment epithelium to a patient with retinitis pigmentosa. Arch Ophthalmol. 2004 Aug;122(8):1159-65. doi: 10.1001/archopht.122.8.1159.
PubMed 15302656Radtke ND, Seiler MJ, Aramant RB, Petry HM, Pidwell DJ. Transplantation of intact sheets of fetal neural retina with its retinal pigment epithelium in retinitis pigmentosa patients. Am J Ophthalmol. 2002 Apr;133(4):544-50. doi: 10.1016/s0002-9394(02)01322-3.
PubMed 11931789Radtke ND, Aramant RB, Seiler M, Petry HM. Preliminary report: indications of improved visual function after retinal sheet transplantation in retinitis pigmentosa patients. Am J Ophthalmol. 1999 Sep;128(3):384-7. doi: 10.1016/s0002-9394(99)00250-0.
PubMed 10511047
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study in Retinal Transplantation for Retinitis Pigmentosa.
- ClinicalTrials.gov ID
- NCT00345917
- Acronym / sponsor ID
- 20050137
- Conditions
- Retinitis Pigmentosa.
- Keywords
- Retinitis Pigmentosa, Retinal Transplant, Fetal Tissue, Early treatment diabetic retinopathy study, 20/200 or worse.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radtke, Norman D., M.D.
- Collaborators
- Foundation Fighting Blindness
- Study start
- Feb 2002
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.
Detailed description
The aim of this clinical trial is to test the safety of transplanting human fetal neural retinal tissue and retinal pigment epithelium into the eyes of human patients with retinitis pigmentosa. Vision in the eye to be operated on will be the poorer vision of both eyes and must be 20/200 or worse. "Retinal tissue", the layers in the back of the eye, consists of neural retina and retinal pigment epithelium. "Neural retina" is the nerve cell layer that processes light into vision. The "photoreceptor cells" in the neural retina detect the light and transform it into electrical signals, which are then transferred to the brain by other retinal cells. "Retinal pigment epithelium" (RPE) is the layer behind the neural retina which helps both to nourish the cells of the neural retina and also to get rid of waste products. The fetal tissues used in this study will be derived from dead fetuses in the first 9-16 weeks of pregnancy obtained from elective abortions.
Fetal retinal transplantation is highly experimental. The research will be conducted in accordance with the prohibitions regarding the use of human fetal tissue described in Public Law 103-43, section 498B. There will be no compensation for the donor. The research will be conducted in accordance with any applicable Federal, State and local laws.
First, the technical application of the implantation instrument and its safety in the transplantation will be demonstrated in patients with 20/200 vision in one eye or worse, with functional acuity in the contra lateral eye.
Secondly, the human fetal retinal tissue will be placed in the areas beneath the retina where presently the patient has atrophy of the retinal pigment epithelium and poor retinal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject must have decreased central visual acuity of 20/200 or worse in one eye by ETDRS vision testing for a duration of at least one year in the operated eye and have the diagnosis of retinitis pigmentosa; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200.
- Subject is older than 21 years of age
- Patient is willing to return for follow-up visits
- Patient has signed informed consent for retinal transplantation
- Patient has undergone microperimetry and Goldmann visual field testing.
Key exclusion criteria (12 listed)
- Patient having a central visual acuity of better than 20/200 in one eye by ETDRS or vision worse than 20/200 in one eye by ETDRS for a duration of less than one year
- Unwilling to sign an informed consent
- Patient under 21 years of age
- Patient having medical problems that are contraindicatory for short-term anesthesia
- Patient unwilling to return for follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal transplantation instrument | Device | – |
| Fetal tissue. | Device | – |
Primary outcome
Snellen
Visual acuity
Microperimetry
Goldmann visual field
Optical coherent tomography
Fluorescein angiography
1 secondary outcome
No rejection of transplant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Results publication: PubMed 15302656Radtke ND, Aramant RB, Seiler MJ, Petry HM, Pidwell D. Vision change after sheet transplant of fetal retina with retinal pigment epithelium to a patient with retinitis pigmentosa. Arch Ophthalmol. 2004 Aug;122(8):1159-65. doi: 10.1001/archopht.122.8.1159.
- Results publication: PubMed 11931789Radtke ND, Seiler MJ, Aramant RB, Petry HM, Pidwell DJ. Transplantation of intact sheets of fetal neural retina with its retinal pigment epithelium in retinitis pigmentosa patients. Am J Ophthalmol. 2002 Apr;133(4):544-50. doi: 10.1016/s0002-9394(02)01322-3.
- Results publication: PubMed 10511047Radtke ND, Aramant RB, Seiler M, Petry HM. Preliminary report: indications of improved visual function after retinal sheet transplantation in retinitis pigmentosa patients. Am J Ophthalmol. 1999 Sep;128(3):384-7. doi: 10.1016/s0002-9394(99)00250-0.
- Retina Vitreous Resource CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman D. Radtke, M.D. principal investigator
Norman D. Radtke, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retinal transplantation instrument and Fetal tissue. in people with Retinitis Pigmentosa., run by Radtke, Norman D., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snellen. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345917, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.