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Optical Coherence Tomography Angiography Biomarkers in a Bi-monthly Maintenance Dosing Aflibercept in Patients with Neovascular Age-Related Macular Degeneration

The Effect of Intravitreal Aflibercept for Neovascular membrane, Pigment Epithelial Detachment and/or Subretinal Fluid Secondary to Type 1 Choroidal Neovascularization: Quantitative analysis based on OCT and OCT Angiography

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007375
Enrollment
40
Registered
2022-06-10
Start date
2018-05-14
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Intravitreal administration of 2.0 mg Aflibercept was administered to single-group subjects as the first treatment at Visit 2, and 2.0 mg Aflibercept was released twice at 4-week intervals dur

Sponsors

Kyung Hee University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Active choroidal neovascularization confirmed by optical coherence tomography angiography or fluorescein angiography and indocyanine green angiography - When the subretinal fluid accompanied by irregular elevation of the retinal pigment epithelium is confirmed by optical coherence tomography - In cases where choroidal neovascularization is observed in optical coherence tomography angiography or fluorescein angiography and indocyanine green angiography 2. Male or female patients over 50 years of age who have signed the informed consent form 3. In the absence of active ocular or systemic disease 4. Patients who understand the process of this clinical trial, are cooperative, and are judged to be able to participate by the end of the clinical trial

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Patients participating in other clinical trials 3. If patient have received anti-vascular endothelial growth factor treatment within the last 90 days 4. If patient have received photodynamic therapy 3 times or more or within the last 90 days 5. Clinically prominent diabetic retinopathy or diabetic macular edema 6. Clinically significant scar or atrophy of the fovea 7. Active Intraocular Inflammation or Infection 8. In case of hypersensitivity to Afilbercept and other ingredients in Eylea 9. History of intravitreal triamcinolone injection treatment within the last 3 months 10. History of intravitreal dexamethasone injection treatment within the last 6 months 11. History of use of inhaled or sprayed or dermal steroids for more than 30 consecutive days within the last 3 months 12. History of eye surgery, including vitrectomy, glaucoma surgery, and scleral buckling within the last 3 months (Excluding simple cataract surgery and vision correction surgery) 13. Diagnosed with retinal vascular disease other than age-related macular degeneration 14. Cerebrovascular disease, myocardial infarction diagnosed within the one year

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity

Secondary

MeasureTime frame
Choroidal neovascularization, retinal pigment epithelial detachment, subretinal fluid change and central subfield thickness change

Countries

Korea, Republic of

Contacts

Public ContactKyungSuk Yeo

Kyung Hee University Hospital

oplasik@hanmail.net+82-2-958-8451

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 10, 2026