Real World Outcomes of Intravitreal Anti-vascular Endothelial Growth Factors for Neovascular Age Related Macular Degeneration in Taiwan

NCT03324542 | Completed

• 1 other identifier: 171009
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose To report the long-term efficacy of patients with neovascular age-related macular degeneration (nAMD) treated with anti-vascular endothelial growth factor (VEGF) in Changhua Christian Hospital in Taiwan. Method Retrospective case series of patients with nAMD that were treated with intravitreal injection of anti-VEGF and had a minimum follow up of 48 months. Every patient was initially treated with 3 loading doses of either bevacizumab or ranibizumab, followed by a loose treat and extend regimen. Eyes were divided into 2 groups according to whether aflibercept was later used as a rescue therapy (group 2) or not (group 1). Patients underwent best-corrected visual acuity (BCVA) testing, optical coherence tomography, and ophthalmic examination at baseline and all the scheduled follow-up visits.

Conditions

AMD

Outcome Measures

Primary Outcomes (2)

• Wilcoxon test

  A statistical comparison of average of two dependent samples

  Baseline, 12 month, 24 month, 36 month, 48 month.

• Mann-Whitney U test

  A non-parametric test used to assess for significant differences in a scale or ordinal dependent variable by a single dichotomous independent variable.

  baseline, 48 month

Secondary Outcomes (2)

• Pair t test

  baseline, 48 month

• Independent t test

  48 month

Interventions

Aflibercept [Eylea] DRUG

Anti-vascular endothelial growth factor (VEGF)

Also known as: Ranibizumab [Lucentis], Bevacizumab [Avastin]

Eligibility Criteria

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

Study Population

Retrospective case series of patients with nAMD that were treated with intravitreal injection of anti-VEGF and had a minimum follow up of 48 months. Every patient was initially treated with 3 loading doses of either bevacizumab or ranibizumab.

You may qualify if:

• Patients with nAMD that were treated with intravitreal injection of anti-VEGF and had a minimum follow up of 48 months

You may not qualify if:

• Loss follow over 1 year.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

鄭**

Changhua, 秀水鄉, 504, Taiwan

Location

Related Publications (1)

• Yang BC, Chou TY, Chen SN. Real-world outcomes of intravitreal antivascular endothelial growth factors for neovascular age-related macular degeneration in Taiwan: A 4-year longitudinal study. Taiwan J Ophthalmol. 2019 Dec 13;9(4):249-254. doi: 10.4103/tjo.tjo_34_19. eCollection 2019 Oct-Dec.

  PMID: 31942430 DERIVED

MeSH Terms

Interventions

aflibercept; Ranibizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 27, 2017
• Study Start: April 3, 2017
• Primary Completion: October 13, 2017
• Study Completion: October 15, 2017
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)