- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391219
Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients
Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients.
This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil injection with Bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion.
Methods:
In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + Fasudil" and in injected intravitreally for 3 times monthly. In "Bevacizumab+Fasudil" group patients receive two injections at each session Bavacizumab and Fasudil. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Ramin Noorinia, MD
- Phone Number: 982122591616
- Email: labbafi@hotmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Ophthalmic Research Center
-
Contact:
- Ramin Noorinia, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Branch retinal vein or central retinal vein occlusion Previous at least 3 intravitreal antiVEGF injection Macular edema in SD-OCT CMT = >250 microns BCVA equal or lesd than 20/40
Exclusion Criteria:
- Moderate or severe corneal opacity Significant cataract obscuring retinal exam or OCT Glaucoma History of vitreoretinal surgery Diabetic retinopathy Macular disease (AMD,ERM,VMT Kidney or Liver disease Uncontrolled or moderate or severe Anemia Uncontrolled hypertention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: intravitreal Bevacizumab
|
1.25 mg/0.05 cc bevacizumab
|
Active Comparator: intravitreal Bavacizumab and Fasudil
|
1.25 mg/0.05
cc bevacizumab and 0.15mg/0.05
cc fasudil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure Macular Thickness
Time Frame: 9 month
|
Optical Coherence Tomography
|
9 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure Visual acuity
Time Frame: 9 month
|
Snellen chart
|
9 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Membrane Transport Modulators
- Protein Kinase Inhibitors
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Bevacizumab
- Fasudil
Other Study ID Numbers
- 96299
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinal Vein Occlusion
-
University of TorontoOntario Research FundUnknownCentral Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Central Retinal Artery Occlusion | Branch Retinal Artery OcclusionCanada
-
University of TorontoPfizer; Unity Health Toronto; Canadian Heart Research Centre; Ontario Association... and other collaboratorsUnknownThrombosis | Central Retinal Vein Occlusion | Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Retinal Vein ThrombosisCanada
-
Palo Alto Medical FoundationTerminatedCentral Retinal Vein Occlusion | Branch Retinal Vein OcclusionUnited States
-
Hanscom, Thomas, M.D.Genentech, Inc.CompletedCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionUnited States
-
Tokyo Medical UniversityUnknownCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionJapan
-
Justis EhlersRegeneron PharmaceuticalsCompletedCentral Retinal Vein Occlusion | Diabetic Macular Edema | Retinal Vein Occlusion | Branch Retinal Vein OcclusionUnited States
-
Hoffmann-La RocheChugai PharmaceuticalCompletedCentral Retinal Vein Occlusion | Macular Edema | Hemiretinal Vein OcclusionUnited States, Korea, Republic of, Brazil, Japan, United Kingdom, China, Argentina, Australia, France, Hungary, Italy, Poland, Spain, Singapore, Austria, Czechia, Germany, Hong Kong, Israel, Portugal, Russian Federation, Taiwan
-
Anders KvantaCompletedCentral Retinal Vein OcclusionSweden
-
He Eye HospitalUnknownCentral Retinal Vein OcclusionChina
-
He Eye HospitalUnknownBranch Retinal Vein OcclusionChina
Clinical Trials on injection bevacizumab
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedCervical Cancer | Glioblastoma | Ovarian Cancer | Lung Cancer | Rectal CancerChina
-
National Taiwan University HospitalTerminatedHemophilia | SynovitisTaiwan
-
Shahid Beheshti University of Medical SciencesActive, not recruitingDiabetic Macular EdemaIran, Islamic Republic of
-
Shahid Beheshti University of Medical SciencesUnknownRetinal Vein Occlusion With Macular EdemaIran, Islamic Republic of
-
Shahid Beheshti University of Medical SciencesUnknownRefractory Diabetic Macular EdemaIran, Islamic Republic of
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Withdrawn
-
Anders KvantaCompleted
-
National Taiwan University HospitalActive, not recruiting
-
Instituto de Olhos de GoianiaUnknownAge Related Macular DegenerationBrazil
-
Vastra Gotaland RegionRecruiting