Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT03497000 - Effects of OCTA-guided PDT in Acute CSC N/A
Recruiting NCT03692169 - The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC
Not yet recruiting NCT02215330 - A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy Phase 2/Phase 3
Completed NCT01990677 - Eplerenone for the Treatment of Central Serous Chorioretinopathy N/A
Completed NCT01971190 - Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy Phase 2
Active, not recruiting NCT00403884 - Selective RPE Laser Treatment (SRT) for Various Macular Diseases N/A
Recruiting NCT05570591 - Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy N/A
Recruiting NCT05589974 - Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
Completed NCT05104138 - Eplerenone Versus PDT: Comparative Study by OCTA
Completed NCT01880788 - Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD N/A
Terminated NCT01982383 - Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy N/A
Completed NCT01327170 - Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy N/A
Completed NCT01019668 - Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy N/A
Recruiting NCT06346405 - Central Serous Chorioretinopathy and Micropulse Laser Treatment
Recruiting NCT02141308 - OCT in Rare Chorioretinal Diseases
Completed NCT01822561 - Eplerenone for Central Serous Chorioretinopathy Phase 2
Completed NCT00802906 - Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC) N/A
Withdrawn NCT05679180 - Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE N/A
Completed NCT05686421 - Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations N/A
Completed NCT03758963 - Selective Retina Therapy With 'R:GEN' in Patients With Central Serous Chorioretinopathy N/A