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CompletedNCT03679156Updated Sep 20, 2018

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

An observational study in Neovascular Age-related Macular Degeneration, sponsored by Hospital Hietzing. Completed. Open to participants aged 66 Years to 98 Years. Per ClinicalTrials.gov, last updated 2018-09-20.

Sponsored by Hospital Hietzing · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
18
Ages
66 Years to 98 Years
Sex
All
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Study 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).

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Conditions studied

  • Neovascular Age-related Macular Degeneration
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In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 18 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Hospital Hietzing is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
66 Years to 98 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Inclusion and exclusion criteria corresponded to the criteria of the MANTA study

Exclusion criteria

Exclusion Criteria:

  • Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
18 participants (actual)
Patient registry
No

Interventions

  • DeviceOCT

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

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What researchers measure

Primary outcomes

  1. visual acuity

    visual acuity testing was performed

    Time frame: 93 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03679156
Lead sponsor
Hospital Hietzing
Responsible party
Dr. Clara Wernigg (Dr., Hospital Hietzing) — Principal investigator
First posted
Sep 20, 2018
Start date
May 30, 2016
Primary completion
Nov 2, 2016
Completion
Apr 15, 2017
Last update
Sep 20, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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