Intravitreal Aflibercept Injection for the Treatment of Submacular Vascularized Pigment Epithelial Detachment (EVEN)
Verified November 2012 by Southern California Desert Retina Consultants, MC
Information provided by (Responsible Party):
Southern California Desert Retina Consultants, MC
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
This study will evaluate the use of intravitreal aflibercept (anti-VEGF therapy) in patients with a type of macular degeneration known as vascularized pigment epithelial detachment. Previous studies have shown a generally poor outcome in treating this difficult to treat form of wet macular degeneration. More recently, multiple pilot studies have shown positive benefits to using anti-VEGF therapy. This study will evaluate the safety and efficacy of treating vascularize pigment epithelial detachment associated with wet macular degeneration with intravitreal aflibercept injection.
Submacular Vascularized Pigment Epithelial Detachments
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open Label Study: Intravitreal Aflibercept Injection for the Treatment of Submacular Vascularized Pigment Epithelial Detachment.
Primary Outcome Measures:
- Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change in BCVA (Best Corrected Visual Acuity) from baseline measured at 4 meters on an ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 12 months
- Anatomic [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Detailed anatomic descriptions and grading of lesion components and multi-modal anatomical changes (i.e. FP/FA, ICG, and OCT [Optical Coherence Tomography] findings) in a standardized fashion in a reading center setting at baseline and subsequent follow-up visits.
Secondary Outcome Measures:
- Proportion of eyes reaching BCVA greater than or equal to 20/200 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Proportion of eyes gaining greater than or equal to 0, 5, and 15 letters on ETDRS chart. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Proportion of eyes losing greater than 5 and 15 letters on ETDRS chart [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mean reduction in central macular thickness from baseline (central 1mm subfield) as measured on an OCT. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Mean changes in choroidal neovascular lesion (CNV) size on fluorescein angiography (FA) and fundus photography (FP) from baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Absence or complete resolution of subretinal fluid and cystoid macular edema. [ Time Frame: 12 monts ] [ Designated as safety issue: No ]
- Mean number of injections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Status of fluorescein staining or leakage (increased or decreased) from baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Ocular safety outcome including ocular complications, i.e. RPE tears, uveitis, endophthalmitis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Systemic safety outcome including cardiovascular events, cerebral vascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
All subjects will receive aflibercept
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Any prior treatment of neovascular AMD in eye for proposed enrollment (non-naïve eye), including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior treatment for neovascular AMD.
- Known serious allergies to aflibercept, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine Solution).
- Contraindication to pupillary dilation in study eye.
- Any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements.
- Presence of any advanced systemic condition or end-stage disease, advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study.
- Previous therapeutic radiation in the region of the study eye.
- Prior retinal pigment epithelial (RPE) tear in study eye.
- Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days.
- Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months
- Prior therapy for AMD (except minerals and vitamins), including laser.
- Prior vitrectomy
- Presence of any causes of CNV and PED other than due to AMD.
- Presence of any substantial ocular disease (other than the CNV and PED) that may compromise vision in the study eye and/or confound interpretation of the data; e.g. substantial cataracts, concomitant diabetic retinopathy affecting the macula, 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.
- Presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters of myopia or axial length of ≥ 25mm), choroidal rupture, multifocal choroiditis, etc.
- Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening
- Serous PED without neovascularization and polypoidal choroidal vasculopathy (PCV) lesions are excluded.
- Prior or current systemic anti-VEGF
- Prior (within 90 days of Day 0) or current corticosteroid therapy (oral or intravenous corticosteroid treatments).
- Sexually active men* or women of child-bearing potential** who are unwilling to practice adequate contraception during the study (adequate contraception 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. ** Post-menopausal 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.
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: NCT01722656
|Jules Stein Eye Institute
|Los Angeles, California, United States, 90095 |
|Contact: Jackie Sanguinet |
|Principal Investigator: David Sarraf, MD |
|Southern California Desert Retina Consultants
|Palm Desert, California, United States, 92211 |
|Contact: Kim Walther 760-340-2394 ext 229 firstname.lastname@example.org |
|Contact: Tiana Gonzales 760-340-2394 ext 232 email@example.com |
|Principal Investigator: Clement K Chan, M.D. |
|Sub-Investigator: Steven G Lin, M.D. |
|Sub-Investigator: Maziar Lalezary, M.D. |
|Black Hills Regional Eye Institute
|Rapid City, South Dakota, United States, 57701 |
|Contact: Buffi Green 605-719-3307 firstname.lastname@example.org |
|Principal Investigator: Prema Abraham, M.D. |
Southern California Desert Retina Consultants, MC
||Clement K Chan, M.D.
||Southern California Desert Retina Consultants
No publications provided
||Southern California Desert Retina Consultants, MC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 2012
||November 5, 2012
||United States: Food and Drug Administration
Keywords provided by Southern California Desert Retina Consultants, MC:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014