Age-Related Macular Degeneration, Neovascularization, Choroidal
Conditions
Keywords
Non-exudative type 1 macular neovascularization (MNV)
Brief summary
The overall goal of the proposed research project is to provide evidence that a specific subtype of neovascularization that may develop in eyes with age-related macular degeneration (AMD) prevents vision loss. This concept challenges the current view that the development of neovascularizations in AMD represents a harmful event in general. Notably, before the era of anti-vascular endothelial growths factor (VEGF) therapy, destruction and surgical removal of neovascular membranes have been tested as treatment options for neovascular AMD. This research project aims to substantiate the hypothesis that type 1 macular neovascularization (MNV) is intrinsically protective, in sense of a positive response to the degenerative processes in AMD. This concept has actually been proposed by pathologists decades ago but has not been systematically investigated in vivo. With the immense advances in retinal imaging, 'sub-clinical', non-exudative type 1 MNVs that are located beneath the retinal pigment epithelium (RPE) can now be detected non-invasively and characterized in vivo. There is currently a growing body of evidence that photoreceptor and RPE degeneration is indeed slowed down in eyes exhibiting type 1 MNV. However, the proof of a direct protective effect of non-exudative type 1 MNV on visual function in AMD is lacking. Here, the aim is to demonstrate relative preservation of function along with preserved structure in the immediate vicinity of type 1 MNV, while there is progressive loss of sensitivity and degeneration in the surrounding tissue.
Interventions
None listed
Sponsors
National Eye Institute (NEI)
University of Utah
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
1. Males and females aged 50 years and older of all ethnicities. 2. AMD in at least one eye (study eye). 3. Type 1 macular neovascularization (MNV) in the study eye (to be confirmed by UREAD Reading Center at the Screening and Baseline Visit): 1. Localized presence of a dense vascular network between Bruch's membrane and retinal pigment epithelium (RPE) on optical coherence tomography angiography (OCT-A) and a double-layer / shallow irregular RPE elevation (SIRE) sign on structural OCT. 2. MNV lesion does not exceed the image frame of the 9x9 OCT-A scan. 4. Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging and fundus-controlled perimetry (FCP) testing. 5. Ability to comply with study protocol timelines.
Exclusion criteria
Intermediate AMD group (original cohort):
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in mesopic retinal sensitivity assessed by Fundus-controlled Perimetry (FCP). | At months 36 from baseline. | This sensitivity change will be compared between (I) retinal areas colocalizing with non-exudative type 1 MNV (test-point group I) and (II) retinal areas without evidence of MNV (testpoint group II). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes over time of qualitative and quantitative structural biomarkers for disease progression. | At months 36 from baseline. | These changes will be compared between (I) retinal areas co-localizing with non-exudative type 1 MNV and (II) retinal areas without evidence of MNV. |
| Mean change over time in dark-adapted retinal sensitivity assessed by Fundus-controlled Perimetry (FCP). | At months 36 from baseline. | This sensitivity change will be compared between (I) retinal areas colocalizing with non-exudative type 1 MNV (test-point group I) and (II) retinal areas without evidence of MNV (testpoint group II). |
Countries
United States
Outcome results
None listed