The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy (CONTAIN)

Wills Eye

Status and phase

Completed

Phase 2

Conditions

Central Serous Chorioretinopathy

Treatments

Drug: Intravitreal Aflibercept Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01710332

CSRII

20121564 (Other Identifier)

Details and patient eligibility

About

A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Full description

Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.