The Injection Burden Clinical Trial
Official title:
Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration
| NCT number | NCT02126904 |
| Other study ID # | 1310006 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | April 27, 2014 |
| Last updated | April 28, 2014 |
| Start date | January 2012 |
| Verified date | April 2014 |
| Source | Yokohama City University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Institutional Review Board |
| Study type | Observational |
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept. Exclusion Criteria: - patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Yokohama City University Medical Center | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Yokohama City University Medical Center | Novartis Pharmaceuticals |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to recurrence after induction phase | Time frame depends on patients because recurrence time is different. | More than 3 months from baseline | Yes |