Clinical trial NCT02328209: Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exudative Age-related Macular Degeneration
Lead sponsor: Mie University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: A change from baselines best corrected visual acuity at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: A drop-out rate of the 3 and 12 months
timeFrame: 3 and 12 months
measure: A treatment continuance rate until 24 months
timeFrame: 24 months
measure: A change of best corrected visual acuity at 12 months
timeFrame: 12 months
measure: A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Tsu
country: Japan
facility: Mie University Graduate School of Medicine
Study officials:
affiliation: Mie University
name: Mineo Kondo
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.1056/NEJMoa054481.