NCT06717139

Recurrence and Predictive OCT Biomarkers in Quiescent Neovascular AMD

Active, enrolled Last updated 3 February 2025

What this trial tests

trial in Retinal Diseases in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 March 2023

Primary endpoint
9 May 2026

9 May 2027

Quick facts

Lead sponsor	St. Erik Eye Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	220
Start date	9 March 2023
Primary completion	9 May 2026
Estimated completion	9 May 2027
Sites	1 location across Sweden

Conditions studied

• Retinal Diseases — all drugs for Retinal Diseases →
• Macular Degeneration — all drugs for Macular Degeneration →
• Neovascular (Wet) Age-Related Macular Degeneration — all drugs for Neovascular (Wet) Age-Related Macular Degeneration →

Sponsor

St. Erik Eye Hospital

Who can join

55 and older, any sex, with Retinal Diseases or Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Age-related macular degeneration (AMD) is the most common cause of severe visual impairment and blindness in elderly patients. The central part of the retina is called the macula and is very important for visual acuity. In wet AMD, blood vessels grow under the macula and leak fluid, which leads to swelling in the macula and vision loss. Patients who develop wet AMD are treated with injections into the eye. Today, the treatment can be stopped when the patient has reached an interval of six months between the injections, without showing any signs of disease activity. However, it is not unusual for the swelling in the macula to return and the injections then must be resumed. Today, it is not known exactly how many patients suffer from active disease recurrence, or at what point of time the recurrence usually happens. Furthermore, it remains unclear which patients are at a higher risk of active disease recurrence.

Optical coherence tomography (OCT) is a simple and quick measurement method, similar to taking a photograph of the inside of the eye, to investigate whether there is swelling or other changes in the macula. With OCT, the retina is measured with infrared light. With OCT angiography (OCT-A), which is done in the same simple way, it is also possible to visualize the diseased blood vessels and other changes in the retina.

Under the retina is the choroid layer of the eye, OCT can also be used to measure the thickness and circulation of the choroid.

No large prospective studies have investigated changes on OCT, changes in the diseased vessels on OCT-A, choroidal thickness and choroidal circulation on OCT, and the risk of recurrence of disease requiring treatment in wet AMD.

The study will be conducted as a prospective study at St. Erik's Eye Hospital, a total of 220 patients with wet AMD, where the treatment interval has been extended to 6 months without signs of disease activity, will be included in the study and followed for 18 months, i.e. up to two years after the last injection. Patients with disease recurrence during the follow-up period will be withdrawn from the study and resume treatment.

The aim of the study is to see if there is a relationship between specific changes on OCT and OCT angiography and later recurrence in wet AMD, to investigate how many patients experience disease recurrence and to find out when the recurrence usually occurs. No previous prospective study has investigated these different parameters.

Increased knowledge of how many patients experience recurrence of wet AMD requiring treatment, as well as a deeper understanding of which patients are at greater risk of recurrence, could have a major impact on the planned follow-up in this population. Furthermore, by improving the conditions for being able to identify recurrences earlier, the risk of irreversible vision loss could also decrease in this patient group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.