Optimizing the Treatment Strategy for Age-related Macular Degeneration

NCT04420923 | Active Not Recruiting DMC

• 1 other identifier: 90953
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare two different treatment protocols for wet macular degeneration; the new protocol called "Observe and Plan" against the current standard protocol "Treat and Extend". Studies suggest that patients achieve equally good visual acuity with fewer controls and that they are more satisfied with the new protocol.

Conditions

Wet Macular Degeneration

Keywords

Outcome Assessment, Health Care

Outcome Measures

Primary Outcomes (2)

• Visual acuity

  Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test.

  1 year

• Visual acuity

  Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test

  2 years

Secondary Outcomes (6)

• Patient satisfaction assessed by NEI-VFQ-25

  1 year

• Patient satisfaction assessed by NEI-VFQ-25

  2 years

• Number of injections

  1 year

• Number of controls

  1 year

• Number of injections

  2 years

Study Arms (2)

Observe-and-Plan

EXPERIMENTAL

Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne.

Other: Observe and Plan

Treat-and-Extend

ACTIVE COMPARATOR

Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.

Other: Treat-and-Extend

Interventions

Observe and Plan OTHER

First the individual interval between the injections of anti-VEGF (vascular endothelial growth factor) is established by observing the time from the loading dose to recurrence of the disease. The patient will come to control every four weeks to establish this interval. Second, the patient will receive injections at intervals that are two weeks shorter than the observed period. 2-3 injections are given before the next control. The control should be no later than six months ahead.

Observe-and-Plan

Treat-and-Extend OTHER

At the first control 4 weeks after the loading dose, the ophthalmologist assesses whether the macula is still wet or whether the macula is dry. In case of wet macula, the patient receives a new injection on the same day and a new control in 4 weeks. If the macula is dry, the patient will return in 2 weeks for the next injection, ie the injection interval is extended from 4 to 6 weeks. Patients will be controlled every time they are to receive an intravitreal injection. If the macula is dry, the injection interval will be extended by 2 weeks and if the macula is wet the interval is shortened by 2 weeks. The shortest interval will be 4 weeks.

Also known as: Standard treatment

Treat-and-Extend

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed age-related macular degeneration according to criteria.
• new diagnose of active CNV verified with OCTA or FA / ICGA.
• BCVA ≥ 20/200 measured with ETDRS visual acuity chart
• written informed consent

You may not qualify if:

• Eyes formerly treated with anti-VEGF, photodynamic therapy, radiation therapy, transpupillary thermotherapy or focal laser photocoagulation involving the macular area.
• Geographic atrophy and subretinal fibrosis affecting the patient's visual acuity.
• Any other ongoing eye disease that influences patient's visual acuity, such as glaucoma with central vision loss, proliferative diabetic retinopathy, diabetic macular edema or chronic uveitis.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Molde Hospital: collaborator
• Alesund Hospital: collaborator

Study Sites (3)

Ålesund Hospital

Ålesund, Norway

Location

Molde Hospital

Molde, Norway

Location

Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital

Trondheim, N-7006, Norway

Location

Related Publications (1)

• Mantel I, Niderprim SA, Gianniou C, Deli A, Ambresin A. Reducing the clinical burden of ranibizumab treatment for neovascular age-related macular degeneration using an individually planned regimen. Br J Ophthalmol. 2014 Sep;98(9):1192-6. doi: 10.1136/bjophthalmol-2013-304556. Epub 2014 Apr 10.

  PMID: 24729031 BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Dordi Austeng, MD PhD

  Norwegian University of Science and Technology, Fac MH, INB

  PRINCIPAL INVESTIGATOR

• Marit Fagerli, MD

  Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital

  STUDY DIRECTOR

• Jorunn Helbostad, Professor

  Norwegian University of Science and Technology, Fac MH, INB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 20, 2020
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available on request after publication.
• Access Criteria: The requests will be evaluated by the research group at the institute.

Locations

NO (3)