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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
NCT01710332
First received: October 16, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Central Serous Chorioretinopathy
Drug: Intravitreal Aflibercept Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Safety of intravitreal aflibercept injection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.


Secondary Outcome Measures:
  • Change in vision based on letter score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravitreal Aflibercept Injection (x4)
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
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).

Other Name: Eylea
Experimental: Intravitreal Aflibercept Injection (x6)
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
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).

Other Name: Eylea

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710332

Locations
United States, Pennsylvania
Mid Atlantic Retina- Huntingdon Valley
Huntingdon Valley, Pennsylvania, United States, 19006
Mid Atlantic Retna- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Allen Ho, MD
  More Information

No publications provided

Responsible Party: Brian Burke, MPH, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01710332     History of Changes
Other Study ID Numbers: CSRII, 20121564
Study First Received: October 16, 2012
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
Persistent
Central
Serous
Chorioretinopathy
Regeneron
CSR
CSCR

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014