To visualize the different components of RAP lesions with high resolution Doppler OCT, and to evaluate the change in intra- and transretinal flow after treatment.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Structural changes and intra-/transretinal blood flow.
Secondary outcome
visual acuity
fundusphotography
FA/ICG
SD-OCT
Background summary
Retinal angiomatous proliferation (RAP) is a distinct form of neovascular
age-related macular degeneration (ARMD) that responds poorly to anti-VEGF
monotherapy. It is difficult to demonstrate RAP with conventional imaging
(fluorescein or indocyanine angiography). Recently, we were able to demonstrate
abnormal flow corresponding to intraretinal neovascularisation in
treatment-naïve RAP patients with high resolution Doppler Optical Coherence
Tomography (OCT) imaging.
Study objective
To visualize the different components of RAP lesions with high resolution
Doppler OCT, and to evaluate the change in intra- and transretinal flow after
treatment.
Study design
Prospective, observational cohort study.
Study burden and risks
Participants undergo treatment and follow-up through routine clinical care.
With the exception of a single extra study-related visit, measurements will be
combined with regular clinical visits. There are no anticipated major side
effects associated with Doppler-OCT measurements. Burden is considered to be
low. Study-related examinations will be performed at 0, 2, 4 and 18 weeks.
These will take about two hours (0 and 18 wks) and one hour (2 and 4 wks)
respectively. Total time: 6 hours.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age * 60 years
Diagnosis of RAP based on fundus photography, FA and/or ICG
The study eye has not been treated for exudative ARMD for at least one year (i.e. no treatment with anti-VEGF, periocular steroids or laser in the study eye within the last year). The specific RAP location has to be treatment-naïve for laser
Informed consent
Exclusion criteria
Ocular surgery within the last 3 months, with the exception of uncomplicated cataract surgery.
Participation in another ophthalmic trial requiring follow-up examinations or using an investigational drug within the last 12 weeks
Other active ocular diseases which irreversibly compromise or, during follow-up, are likely to compromise visual acuity or good visualization of the study eye including ocular surgery scheduled within 3 months after start of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48119.078.14 |