NCT03838679

Imaging of the Angiofibrotic Switch in Neovascular AMD

Status unknown Last updated 20 February 2020

What this trial tests

trial testing Best-corrected Visual acuity testing (BCVA) in Age-related Macular Degeneration in 120 participants. Status unknown.

Timeline

1 May 2019

Primary endpoint
28 April 2022

28 April 2022

Quick facts

Lead sponsor	Medical University of Vienna
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	120
Start date	1 May 2019
Primary completion	28 April 2022
Estimated completion	28 April 2022
Sites	1 location across Austria

Drugs / interventions tested

• Best-corrected Visual acuity testing (BCVA)
• Optical coherence tomography (OCT)
• Color fundus photography (CFP)
• Optical coherence tomography angiography (OCTA)
• Polarization-sensitive optical coherence tomography (PS-OCT)
• Microperimetry (MP)
• Adaptive-optics optical coherence tomography (AO-OCT)
• Fluorescein angiography (FA)

Conditions studied

• Age-related Macular Degeneration — all drugs for Age-related Macular Degeneration →
• Choroidal Neovascularization — all drugs for Choroidal Neovascularization →

Sponsor

Medical University of Vienna

Who can join

50 and older, any sex, with Age-related Macular Degeneration or Choroidal Neovascularization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The content of this research project is to identify the angiofibrotic switch, the transition from angiogenesis to fibrosis, in neovascular age-related macular degeneration (nAMD) longitudinally. Despite optimal treatment about 50% of eyes with nAMD develop fibrosis within 2 years, causing irreversible damage to the retina and functional loss. Objective measurement of fibrosis, however, is challenging, since clinical staging is subjective and current imaging modalities such as color fundus photography (CFP), fluorescein angiography (FA) and optical coherence tomography (OCT) often do not allow clear delineation. Novel imaging modalities such as polarization-sensitive OCT (PS-OCT), OCT angiography (OCTA) and adaptive-optics OCT (AO-OCT) offer identification of fibrous components and microvasculature of fibrotic lesions non-invasively with highest precision and shall thus be used in this study.

Hypotheses: The investigators hypothesize to detect and quantify subclinical (i.e. not detectable on dilated fundus examination) areas of fibrosis using PS-OCT and determine the rate and exact location within the neovascular lesion. Furthermore, the investigators expect neuroretinal and microvascular changes, which will be assessed by AO-OCT and OCTA.

Methods: Eighty eyes of 80 patients with chronic nAMD will be included and examined cross- sectionally to evaluate the accuracy of PS-OCT to detect and quantify fibrosis in comparison to gold standard imaging modalities. In addition, OCTA and AO-OCT will be performed to analyze the relationship between fibrous, neovascular and neuroretinal structures. Furthermore, forty eyes of 40 participants with treatment-naïve nAMD will be included and followed over 12 months with predefined follow-up intervals. Novel non-invasive imaging will be applied to objectively determine the exact time and extent of the angiofibrotic switch in nAMD during state-of-the- art therapy. This approach has not been done before and is clinically relevant for multiple reasons: Firstly, only little is known about the development of fibrosis in AMD during therapy. Secondly, the clinical diagnosis of subretinal fibrosis is subjective and does not allow reliable quantification. Thirdly, current gold standard imaging modalities (i.e. CFP and FA) for detection of fibrosis involve invasive and time-consuming procedures and do not allow three-dimensional analysis. Finally, our study may identify objective endpoints for future interventional trials.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Baseline predictors for subretinal fibrosis in neovascular age-related macular degeneration.
   Roberts PK, Schranz M, Motschi A, Desissaire S, et al · · 2022 · cited 23× · PMID 34996934 · DOI 10.1038/s41598-021-03716-8
2. Morphologic and Microvascular Differences Between Macular Neovascularization With and Without Subretinal Fibrosis.
   Roberts PK, Schranz M, Motschi A, Desissaire S, et al · · 2021 · cited 12× · PMID 34851359 · DOI 10.1167/tvst.10.14.1
3. Subretinal fibrosis secondary to neovascular age-related macular degeneration: mechanisms and potential therapeutic targets.
   Zhang J, Sheng X, Ding Q, Wang Y, et al · · 2025 · cited 11× · PMID 38819041 · DOI 10.4103/nrr.nrr-d-23-01642
4. Automated inter-device 3D OCT image registration using deep learning and retinal layer segmentation.
   Rivas-Villar D, Motschi AR, Pircher M, Hitzenberger CK, et al · · 2023 · cited 5× · PMID 37497506 · DOI 10.1364/boe.493047