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Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension

Sponsor
St. Erik Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04659512
Collaborator
(none)
105
Enrollment
1
Location
32.2
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All study subjects had nAMD and were treated at diagnosis with three monthly aflibercept injections and then subsequently followed in a treat and extend regimen with extensions by two weeks if no signs of disease activity were seen. Hemorrhage, intraretinal macular edema or subretinal fluid were considered signs of disease activity. Patients reaching 12-week intervals without any evidence of disease activity on three consecutive visits, a BCVA between 35-88 letters (Snellen 20/200- 20/20) and a near vision of at least 24 points were eligible for study inclusion.

    If there were signs of recurrent disease activity during the follow-up, study participation was concluded at that point and intravitreal therapy was resumed. Between scheduled visits patients were encouraged to monitor their vision at home using monocular visual assessments and were advised to return earlier than planned if symptoms of visual deterioration or metamorphopsia occurred. At baseline and at every follow-up visit all patients had a full dilated ophthalmic examination. Optical coherence tomography (OCT) images were obtained by using the Zeiss Cirrus OCT instrument (Carl Zeiss Meditec, Inc.,Dublin, Ca). A pigment epithelial detachment (PED) was identified as an elevation of the RPE band and included both serous and fibrovascular PED. Near vision was tested at 40cm with the addition of +3 dioptres to the BCVA refraction. For near vision assessment we used the LIX adult A chart (Ortho-KM, Lund, Sweden) graded in typographical points, the largest text being 24 points and the smallest 4 points.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    105 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Recurrent Neovascular Age-related Macular Degeneration After Discontinuation of VEGF Inhibitors Managed in a Treat and Extend Regimen
    Actual Study Start Date :
    Oct 1, 2017
    Actual Primary Completion Date :
    Feb 28, 2019
    Actual Study Completion Date :
    Jun 6, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Disease recurrence [12 months]

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

    Secondary Outcome Measures

    1. Risk factors for disease recurrence [12 months]

      Effect of age, lesion type, anatomic parameters (PED, geographic atrophy (GA) and sub macular fibrosis), previous episodes of recurrence and total number of injections before suspension, on risk of reactivation.

    2. Visual outcome [12 months]

      Change in BCVA at time of recurrence and after resumed therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Active neovascular AMD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Eriks Eye Hospital Stockholm Sweden 11282

    Sponsors and Collaborators

    • St. Erik Eye Hospital

    Investigators

    • Principal Investigator: David Epstein, Sankt Erik Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anders Kvanta, PI, St. Erik Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT04659512
    Other Study ID Numbers:
    • 20171
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Dec 10, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Dec 10, 2020