Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
| Verified date | September 2018 |
| Source | Hospital Hietzing |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Purpose:
To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with
neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial
growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers
potentially influencing prognosis.
Methods:
18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the
Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean
period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal
anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated
as-needed [pro re nata (PRN)]. Functional and morphological changes were assessed using
spectral domain optical coherence tomography (SD-OCT).
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | April 15, 2017 |
| Est. primary completion date | November 2, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 66 Years to 98 Years |
| Eligibility |
Inclusion Criteria: - Inclusion and exclusion criteria corresponded to the criteria of the MANTA study Exclusion Criteria: - Inclusion and exclusion criteria corresponded to the criteria of the MANTA study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Hietzing |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | visual acuity | visual acuity testing was performed | 93 months |
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