Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment

NCT ID: NCT03833830

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-05-30

Brief Summary

Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).

Detailed Description

Main outcome parameters are:

• Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement)
• Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement).
• Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement)
• Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)

(*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

longterm treatment group

previous treatment (before Optical Coherence Tomography angiography (OCTA)) \>20 injections

Optical Coherence Tomography angiography (OCTA)

Intervention Type: DIAGNOSTIC_TEST

There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group \>20 injections and shortterm treatment group \< 5 injections).

shortterm treatment group

previous treatment (before Optical Coherence Tomography angiography (OCTA)) \< 5 injections

Optical Coherence Tomography angiography (OCTA)

Intervention Type: DIAGNOSTIC_TEST

There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group \>20 injections and shortterm treatment group \< 5 injections).

Interventions

Optical Coherence Tomography angiography (OCTA)

There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group \>20 injections and shortterm treatment group \< 5 injections).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

To be eligible for participation, patients will be required to

• have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or <5 times (shortterm treatment eyes).
• give written consent to participation

Exclusion Criteria

• diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment

• history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc.
• history of papillary disease which might interfere with interpretation of peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV, papillar drusen, optic nerve neuritis, papillar edema etc.
• inability to perform OCTA examination of sufficient quality.
• history of any side effects of Tropicamide eye drops

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cenaug Foundation

UNKNOWN

Sponsor Role: collaborator

Dr. med. Katja Hatz

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Katja Hatz

Head of medical retina department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katja Hatz, MD

Role: PRINCIPAL_INVESTIGATOR

Vista Klinik Binningen

Locations

Vista Klinik

Binningen, Basel-Landschaft, Switzerland

Countries

Switzerland

Other Identifiers

OCTA 2018-02043

Identifier Type: -

Identifier Source: org_study_id