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

Central Serous Chorioretinopathy Clinical Trial

— CONTAIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01710332
• Other study ID #: CSRII
• Secondary ID: 20121564
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 16, 2012
• Last updated: June 24, 2013
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Intravitreal Aflibercept Injection
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).

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Huntingdon Valley	Huntingdon Valley	Pennsylvania
United States	Mid Atlantic Retna- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of intravitreal aflibercept injection	Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.	6 months	Yes
Secondary	Change in vision based on letter score	Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score; Percentage of eyes with 20/40 or better vision; Percentage of eyes with = 15-letter gain from baseline; Percentage of eyes with < 15-letter loss from baseline	6 months	No