Skip to main content
OpenTrials
Completed

NCT Number: NCT04659512

Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Eriks Eye Hospital

Stockholm, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease recurrence

    Time frame: 12 months

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

Secondary outcomes

  1. Risk factors for disease recurrence

    Time frame: 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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

St. Erik Eye Hospital

Other

Registry information

Official study title

Recurrent Neovascular Age-related Macular Degeneration After Discontinuation of VEGF Inhibitors Managed in a Treat and Extend Regimen

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.