Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659512
• Other study ID #: 20171
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: June 6, 2020

Study information

• Verified date: December 2020
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 6, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Sweden	St Eriks Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St. Erik Eye Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease recurrence	The proportion of patients with recurrent disease within 12 months after the last injection.	12 months
Secondary	Risk factors for disease recurrence	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.	12 months
Secondary	Visual outcome	Change in BCVA at time of recurrence and after resumed therapy.	12 months