Clinical trial NCT01710332: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Serous Chorioretinopathy
Keywords: Persistent
Central
Serous
Chorioretinopathy
Regeneron
CSR
CSCR
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Safety of Intravitreal Aflibercept Injection
timeFrame: 6 months
Secondary outcomes:
measure: Change in Vision Based on Letter Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Huntingdon Valley
country: United States
facility: Mid Atlantic Retina- Huntingdon Valley
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retna- Wills Eye Institute
state: Pennsylvania
Study officials:
name: Allen Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitcher JD 3rd, Witkin AJ, DeCroos FC, Ho AC. A prospective pilot study of intravitreal aflibercept for the treatment of chronic central serous chorioretinopathy: the CONTAIN study. Br J Ophthalmol. 2015 Jun;99(6):848-52. doi: 10.1136/bjophthalmol-2014-306018. Epub 2015 Jan 16.