Age-Related Macular Degeneration Clinical Trial
Official title:
Long-Term Follow-up Study of the Phase I/II Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
Verified date | May 2016 |
Source | StemCells, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
This study is being done to determine the long-term safety and possible benefits of transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term follow-up study.
Status | Terminated |
Enrollment | 8 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 51 Years and older |
Eligibility |
Inclusion Criteria: - Must have completed Study CL-N01-AMD - Must be able to provide written informed consent prior to any study related procedures - Agree to comply in good faith with all conditions of the study and to attend all required study visits Exclusion Criteria: - Inability to comply with study procedures or visits - Since enrolling in Study CL-N01-AMD, have entered, or are about to enter another investigational study that, in the opinion of the Principal Investigator (PI), might confound study interpretation. - Received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Retina Foundation of the Southwest | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
StemCells, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and types of serious adverse events | At each of 11 visits over a period of 48 months | Yes | |
Secondary | Frequency and types of adverse events | At each of 11 visits over a period of 48 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05984927 -
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05536297 -
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT04005352 -
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
|
Phase 3 | |
Withdrawn |
NCT02873351 -
A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02802657 -
Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
|
Phase 4 | |
Not yet recruiting |
NCT02864472 -
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
|
Phase 4 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02035722 -
Intravitreal Injections-related Anxiety
|
Phase 2/Phase 3 | |
Completed |
NCT01445548 -
Sirolimus for Advanced Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01048476 -
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01174407 -
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
|
N/A | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00345176 -
Age-Related Eye Disease Study 2 (AREDS2)
|
Phase 3 | |
Completed |
NCT02140151 -
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02555306 -
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT04796545 -
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
|
N/A | |
Completed |
NCT03166202 -
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
|
||
Completed |
NCT01397409 -
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
|
Phase 2 |