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

Exudative Age-related Macular Degeneration Clinical Trial

Official title:

Evaluation of the Efficacy and Continuance Rate of Treatment in Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328209
• Other study ID #: UMIN000014056
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2014
• Last updated: December 26, 2014
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Mie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of the present study is to evaluate the simplified treat and extend regimen using ranibizumab in eyes with wet age related macular degeneration about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. ability to provide written informed consent for this study

2. age>=50years old

3. intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV)

4. best corrected visual acuity>=0.05 -

Exclusion Criteria:

1. past intravitreal anti-vascular endothelial growth factor therapy in the study eye

2. past intravitreal or subtenon injection of steroid therapy in the study eye

3. past vitrectomy therapy in the study eye

4. infection or suspicion of infection in eyes or periocular region

5. severe intraocular inflammation in eyes

6. past allergic reaction for ranibizumab

7. past allergic reaction for fluorescein, indocyanine green or iodine

8. pregnancy (positive pregnancy test) or lactating women

9. other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Japan	Mie University Graduate School of Medicine	Tsu

Sponsors (1)

Lead Sponsor	Collaborator
Mie University

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change from baselines best corrected visual acuity at 24 months		24 months	Yes
Secondary	A drop-out rate of the 3 and 12 months		3 and 12 months	Yes
Secondary	A treatment continuance rate until 24 months		24 months	Yes
Secondary	A change of best corrected visual acuity at 12 months		12 months	Yes
Secondary	A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months		12 and 24 months	Yes