Recurrence and Predictive OCT Biomarkers in Quiescent Neovascular AMD

NCT06717139 | Active Not Recruiting

• 1 other identifier: StErik
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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 Patients with disease recurrence during the follow-up period will be withdrawn from the study and resume treatment.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.

Conditions

Retinal Diseases; Macular Degeneration; Neovascular (Wet) Age-Related Macular Degeneration

Keywords

AMD; biomarker; recurrence; OCT

Outcome Measures

Primary Outcomes (1)

• The association between OCT and OCTA biomarkers and disease recurrence in neovascular AMD

  To investigate the impact of the following OCT-A and OCT biomarkers on the risk of disease recurrence in wet AMD: * Neovascular lesion area, largest lesion diameter, largest vessel diameter, presence of anastomosis and loop patterns and vessel density on OCT-A * CT and CVI on EDI-OCT * The presence of a PED and PED size on OCT

  From enrollment to the end of study at 18 months

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

220 patients that have been treated with intraviteral anti-VEGF injections for neovascular AMD at the retinal clinic at St Erik Eye Hospital, Stockholm, Sweden.

You may not qualify if:

• wet AMD with signs of disease activity (neovascular exudative intraretinal fluid or significant subretinal fluid on OCT, or macular bleeding or exudation on fundus exam). Other coexisting causes for macular edema than AMD (for example central serous chorioretinopathy, retinal vein occlusion or diabetic macular edema).

Sponsors & Collaborators

• St. Erik Eye Hospital: lead

Study Sites (1)

St Erik Eye Hospital

Stockholm, Solna, 17164, Sweden

Location

MeSH Terms

Conditions

Retinal Diseases; Macular Degeneration; Recurrence

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Degeneration; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: March 9, 2023
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2027
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

SE (1)