A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01678872 |
Recruitment Status :
Active, not recruiting
First Posted : September 5, 2012
Last Update Posted : October 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Age-Related Macular Degeneration | Drug: RetinoStat | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | March 2029 |
Estimated Study Completion Date : | March 2029 |

Arm | Intervention/treatment |
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Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
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Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study |
- The incidence of adverse events [ Time Frame: 15 years ]The number of subjects with treatment emergent adverse events.
- The change from baseline in BCVA. [ Time Frame: 15 years ]The change from baseline in Best Corrective Visual Acuity.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have received a subretinal injection of RetinoStat
- Must have been enrolled in Protocol RS1/001/10
Exclusion Criteria:
- Did not receive RetinoStat® as part of the RS1/001/10 protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678872
United States, Iowa | |
University of Iowa Hospitals & Clinics | |
Iowa City, Iowa, United States, 52245 | |
United States, Maryland | |
John Hopkins University Hospital | |
Baltimore, Maryland, United States, 21287-9277 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Peter Campochiaro, MD | John Hopkins University Hospital |
Responsible Party: | Oxford BioMedica |
ClinicalTrials.gov Identifier: | NCT01678872 |
Other Study ID Numbers: |
RS1/002/11 |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | October 12, 2020 |
Last Verified: | October 2020 |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |