Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor

NCT03679156 | Completed

• 1 other identifier: RPE characteristics
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• visual acuity

  visual acuity testing was performed

  93 months

Interventions

OCT DEVICE

Patients were recruited, visual acuity and optical coherence tomography Pictures were taken

Eligibility Criteria

• Age: 66 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) trial \[16\]. These patients received a loading dose of 3 intravitreal injections of anti-VEGF and were subsequently treated as-needed \[pro re nata (PRN)\] \[16\]. From that study population we recruited for another long term follow up visit. Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%) died before the last study visit and 14 former participants (25%) did not approve further study participation.

Sponsors & Collaborators

• Hospital Hietzing: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: May 30, 2016
• Primary Completion: November 2, 2016
• Study Completion: April 15, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share