Exudative Age-related Macular DegenerationNCT02328209
Evaluation of the Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
A study testing ranibizumab in people with Exudative Age-related Macular Degeneration, run by Mie University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Mie University Graduate School of Medicine
Tsu, 5148507
Mineo Kondo, +81592321111 ext. 6461, ganka@clin.medic.mie-u.ac.jp
About this study
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
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.
Read the 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.
- Being tested
- ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | ranibizumab Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change from baselines best corrected visual acuity at 24 months
Measured: 24 months
Secondary outcomes (4)
A drop-out rate of the 3 and 12 months
Measured: 3 and 12 months
A treatment continuance rate until 24 months
Measured: 24 months
A change of best corrected visual acuity at 12 months
Measured: 12 months
A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mineo Kondo, Mie University
- Investigators
- Mineo Kondo, Study chair, Mie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328209
- Sponsor's protocol ID
- UMIN000014056
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17021319Rosenfeld 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.
PubMed 17021318
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02328209
- Acronym / sponsor ID
- UMIN000014056
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mie UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: ranibizumabranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: Lucentis0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks | Drug | ranibizumab |
Primary outcome
A change from baselines best corrected visual acuity at 24 months
Time frame: 24 months
4 secondary outcomes
A drop-out rate of the 3 and 12 months
Time frame: 3 and 12 months
A treatment continuance rate until 24 months
Time frame: 24 months
A change of best corrected visual acuity at 12 months
Time frame: 12 months
A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Results publication: PubMed 17021319Brown 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.
- Results publication: PubMed 17021318Rosenfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mie University Graduate School of Medicine
Tsu, Japan
Mineo Kondo study chair
Mie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ranibizumab in people with Exudative Age-related Macular Degeneration, run by Mie University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change from baselines best corrected visual acuity at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328209, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.