Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration

NCT02328209 | Unknown DMC

• 1 other identifier: UMIN000014056
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Recently studies have shown that intravitreal injection of ranibizumab is effective for age related macular degeneration. However there are problems about injection regimen of maintenance phase. We plan to perform new simplified treat and extend regimen using ranibizumab.

Conditions

Exudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• A change from baselines best corrected visual acuity at 24 months

  24 months

Secondary Outcomes (4)

• A drop-out rate of the 3 and 12 months

  3 and 12 months

• A treatment continuance rate until 24 months

  24 months

• A change of best corrected visual acuity at 12 months

  12 months

• A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months

  12 and 24 months

Study Arms (1)

ranibizumab

EXPERIMENTAL

ranibizumab

Drug: ranibizumab

Interventions

ranibizumab DRUG

0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks

Also known as: Lucentis

ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to provide written informed consent for this study
• age\>=50years old
• intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV)
• best corrected visual acuity\>=0.05 -

You may not qualify if:

• past intravitreal anti-vascular endothelial growth factor therapy in the study eye
• past intravitreal or subtenon injection of steroid therapy in the study eye
• past vitrectomy therapy in the study eye
• infection or suspicion of infection in eyes or periocular region
• severe intraocular inflammation in eyes
• past allergic reaction for ranibizumab
• past allergic reaction for fluorescein, indocyanine green or iodine
• pregnancy (positive pregnancy test) or lactating women
• other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.

Sponsors & Collaborators

• Mie University: lead

Study Sites (1)

Mie University Graduate School of Medicine

Tsu, 5148507, Japan

RECRUITING

Related Publications (2)

• Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

  PMID: 17021319 RESULT

• Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

  PMID: 17021318 RESULT

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mineo Kondo

  Mie University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mie University Graduate School of Medicine

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 31, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

JP (1)