NCT04659512

Brief Summary

The purpose of this study is to investigate prospectively the recurrence rate of active macular neovascularization (MNV) and the visual outcome in patients with nAMD previously on a Treat and Extend regimen where treatment has been discontinued due to disease stability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

December 2, 2020

Last Update Submit

December 9, 2020

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Disease recurrence

    The proportion of patients with recurrent disease within 12 months after the last injection.

    12 months

Secondary Outcomes (2)

  • Risk factors for disease recurrence

    12 months

  • Visual outcome

    12 months

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inactive neovascular AMD reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits.

You may qualify if:

  • Patients with inactive neovascular AMD reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits.
  • BCVA between 35-88 letters (Snellen 20/200- 20/20)
  • Near vision of at least 24 points

You may not qualify if:

  • Active neovascular AMD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Eriks Eye Hospital

Stockholm, 11282, Sweden

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • David Epstein

    Sankt Erik Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

October 1, 2017

Primary Completion

February 28, 2019

Study Completion

June 6, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)