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

NCT03833830 | Completed

• 1 other identifier: OCTA 2018-02043
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups

  in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (\<5 intravitreal injections).

  baseline V0

Secondary Outcomes (4)

• Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)

  baseline V0

• 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)

  baseline V0

• weight

  baseline V0

• height

  baseline V0

Study Arms (2)

longterm treatment group

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

Diagnostic Test: Optical Coherence Tomography angiography (OCTA)

shortterm treatment group

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

Diagnostic Test: Optical Coherence Tomography angiography (OCTA)

Interventions

Optical Coherence Tomography angiography (OCTA) 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).

longterm treatment group; shortterm treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. med. Katja Hatz: lead
• Cenaug Foundation: collaborator

Study Sites (1)

Vista Klinik

Binningen, Basel-Landschaft, 4102, Switzerland

Location

Study Officials

• Katja Hatz, MD

  Vista Klinik Binningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of medical retina department

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: February 7, 2019
• Study Start: January 7, 2019
• Primary Completion: April 2, 2019
• Study Completion: May 30, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CH (1)