- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710332
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy (CONTAIN)
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Huntingdon Valley, Pennsylvania, United States, 19006
- Mid Atlantic Retina- Huntingdon Valley
-
Philadelphia, Pennsylvania, United States, 19107
- Mid Atlantic Retna- Wills Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pre-treatment acuity of 20/40- 20/320
- Macular fluid on optical coherence tomography for greater than 3 months
- Leakage on fluorescein angiography
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Exclusion Criteria:
- Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
- Presence of choroidal neovascularization on enrollment imaging
- Prior vitrectomy in the study eye
- Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- Active ocular infection or inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Prior treatment with systemic anti-VEGF agents
- Cerebrovascular accident or myocardial infarction within the preceding 6 months.
- History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept
- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Contraception is not required for men with documented vasectomy.
- Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intravitreal Aflibercept Injection (x4)
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
|
GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Other Names:
|
Experimental: Intravitreal Aflibercept Injection (x6)
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
|
GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Intravitreal Aflibercept Injection
Time Frame: 6 months
|
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vision Based on Letter Score
Time Frame: 6 months
|
• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Allen Ho, MD
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSRII
- 20121564 (Other Identifier: Western IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Central Serous Chorioretinopathy
-
Shiraz University of Medical SciencesRecruiting
-
Radboud University Medical CenterOogziekenhuis RotterdamRecruitingChronic Central Serous ChorioretinopathyNetherlands
-
Radboud University Medical CenterUniversity of Oxford; University of Cologne; Leiden University Medical Center; University...CompletedChronic Central Serous ChorioretinopathyNetherlands, France, Germany, United Kingdom
-
Università degli Studi di BresciaUnknownChronic Central Serous Chorioretinopathy
-
Manhattan Eye, Ear & Throat HospitalLuEsther T. Mertz Retinal Research CenterCompletedChronic Central Serous ChorioretinopathyUnited States
-
Manhattan Eye, Ear & Throat HospitalCompletedChronic Central Serous ChorioretinopathyUnited States
-
Sun Yat-sen UniversityCompletedAcute Central Serous ChorioretinopathyChina
-
Ankara Universitesi TeknokentCompletedCentral Serous Chorioretinopathy | Chronic Central Serous ChorioretinopathyTurkey
-
Leiden University Medical CenterRadboud University Medical Center; Academisch Medisch Centrum - Universiteit...UnknownChronic Central Serous ChorioretinopathyNetherlands
-
Manhattan Eye, Ear & Throat HospitalAlcon Research; LuEsther T. Mertz Retinal Research CenterCompletedChronic Central Serous ChorioretinopathyUnited States
Clinical Trials on Intravitreal Aflibercept Injection
-
Indonesia UniversityBayerCompletedDiabetic Retinopathy | Diabetic Macular Edema | Clinically Significant Macular EdemaIndonesia
-
Innovent Biologics (Suzhou) Co. Ltd.SuspendedDiabetic Macular Edema | Neovascular Age-related Macular DegenerationChina
-
Chengdu Kanghong Biotech Co., Ltd.TerminatedNeovascular Age-related Macular DegenerationUnited States, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Germany, Hong Kong, Lithuania, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Singapore, Spain, Switzerland, Taiwan
-
Chengdu Kanghong Biotech Co., Ltd.TerminatedNeovascular Age-related Macular DegenerationUnited States, Bulgaria, China, Czechia, Denmark, France, Hungary, Israel, Italy, Latvia, Slovakia, United Kingdom
-
M. Ali Khan, MDUniversity of California, Los Angeles; Southeastern Retina Associates; Eye Associates...RecruitingProliferative Vitreoretinopathy | Retinal Detachment With Multiple Breaks, Unspecified EyeUnited States
-
Kim's Eye HospitalBayerRecruitingRetinal Angiomatous ProliferationKorea, Republic of
-
Instituto de Olhos de GoianiaUnknownChoroidal Retinal NeovascularizationBrazil
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Regeneron PharmaceuticalsCompletedNonproliferative Diabetic RetinopathyUnited States, Germany, Hungary, Japan, Puerto Rico, United Kingdom
-
Regeneron PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationUnited States