Brief Title
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
Official Title
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Brief Summary
A preliminary study to determine the safety and efficacy of intravitreal aflibercept
injection in patients with persistent central serous chorioretinopathy.
Detailed Description
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A
Prospective Pilot Study
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Safety of Intravitreal Aflibercept Injection
Secondary Outcome
Change in Vision Based on Letter Score
Condition
Central Serous Chorioretinopathy
Intervention
Intravitreal Aflibercept Injection
Study Arms / Comparison Groups
Intravitreal Aflibercept Injection (x4)
Description: 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
October 2012
Completion Date
June 2013
Primary Completion Date
June 2013
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Allen Ho, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01710332
Organization ID
CSRII
Secondary IDs
20121564
Responsible Party
Principal Investigator
Study Sponsor
Wills Eye
Collaborators
Regeneron Pharmaceuticals
Study Sponsor
Allen Ho, MD, Principal Investigator,
Verification Date
May 2017