Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab
NCT ID: NCT01845844
Last Updated: 2014-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2013-04-30
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Ranibizumab for Diabetic Macular Edema
NCT01982435
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
NCT02448446
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
NCT01476449
A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
NCT01934556
Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF
NCT03071055
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ranibizumab 0.3mg (12 months)
Intravitreal injection of ranibizumab 0.3mg/0.05cc
Ranibizumab 0.3mg/0.05cc
Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months.
Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.
Ranibizumab 0.3mg (6 months)
Intravitreal injection of ranibizumab 0.3mg/0.05cc
Ranibizumab 0.3mg/0.05cc
Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months.
Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranibizumab 0.3mg/0.05cc
Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months.
Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>=18 years
* Type I/II diabetes mellitus
* Central-involved DME in study eye (OCT CSF \>=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)
* Definite retinal thickening due to diabetic macular edema involving the center of the macula.
* Media clarity, pupillary dilation and individual cooperation for adequate fungus photography and fluorescein angiography.
* Visual Acuity score in study eye \<=80 and \>=20 (approximate Snellen equivalent 20/25 to 20/400).
* History of at least 6 intravitreal bevacizumab injections within the past 9 months and 2 intravitreal bevacizumab injections within the past 2 months.
* No history of an anti-VEGF treatment for DME in the past 3 weeks.
* No other DME treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.
* No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next six months following randomization.
Exclusion Criteria
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another medical investigation or trial within 30 days of randomization
* Known allergy to ranibizumab
* Acute cardiovascular event requiring hospitalization within the past 3 months
* Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study
* Macular edema is considered to be due to a cause other than DME
* An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema
* History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent other than bevacizumab within 9 months prior to randomization
* History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization
* Yag capsulotomy performed within 1 month prior to randomization
* External ocular infection including conjunctivitis, significant blepharitis, etc.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Southeast Retina Center, Georgia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dennis M. Marcus, M.D.
Dr. Dennis M. Marcus Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dennis M Marcus, M.D.
Role: STUDY_DIRECTOR
Southeast Retina Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southeast Retina Center, PC
Augusta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML28713
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.