NEWTON: Aflibercept Injection for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions (NEWTON)
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|ClinicalTrials.gov Identifier: NCT01870427|
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : December 8, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Macular Edema With Central Retinal Vein Occlusions||Drug: Aflibercept (2.0 mg)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NEWTON: A Single-center Open Label Study Evaluating Intravitreal Aflibercept Injection (IAI) for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2016|
Experimental: Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
Drug: Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
- Duration of Intravitreal Aflibercept on Treatment Interval [ Time Frame: 52 Weeks ]Mean number of weeks between each injection where there is no macular edema
- Change in Visual Acuity [ Time Frame: 52 Weeks ]Mean change in EDTRS BCVA
- Retinal Thickness [ Time Frame: 52 Weeks ]Mean change in Central Subfoveal Thickness by OCT
- Adverse Events [ Time Frame: 52 Weeks ]Incidence and severity of ocular and systemic AE's
- Number of Treatments [ Time Frame: 52 Weeks ]Mean number of Intravitreal Injections
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients aged 18 and above with documented history of center-involved macular edema secondary to CRVO.
- Patients must have received treatment for at least 6 months before baseline, with 3 initial loading doses, and evidence of recurrence of edema when extended beyond 4 weeks.
- Protocol refracted ETDRS BCVA of 20/25 to 20/320 (73-24 letters).
- Willing and able to comply with clinic visits and study-related procedures.
- Provide signed informed consent.
- Prior panretinal or macular laser photocoagulation
- Previous use of intraocular corticosteroids or use of periocular corticosteroids within the 3 months prior to day 1
- Prior treatment with systemic anti-VEGF agents
- Presence of iris neovascularization
- Vitreous hemorrhage in the Study Eye
- Traction retinal detachment, or preretinal fibrosis involving the macula
- Diabetic macular edema or diabetic retinopathy, defined as eyes of diabetic patients with more than 1 microaneurysm outside the area of the vein occlusion.
- Infectious blepharitis, keratitis, scleritis, or conjunctivitis.
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal or greater than 30mmHg despite treatment with anti-glaucoma medication)
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced glaucoma, age-related macular degeneration, etc)
- Any concurrent intraocular condition in the study eye (e.g. glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 52 weeks study period to prevent or treat visual loss that might result from that condition.
- 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) *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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870427
|United States, California|
|Northern California Retina Vitreous Associates|
|Mountain View, California, United States, 94040|
|Principal Investigator:||Rahul N Khurana, MD||Northern California Retina Vitreous Associates|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Rahul Khurana, M.D., Principal Investigator, Northern California Retina Vitreous Associates|
|Other Study ID Numbers:||
|First Posted:||June 6, 2013 Key Record Dates|
|Last Update Posted:||December 8, 2016|
|Last Verified:||December 2016|
Central Retinal Vein Occlusion
Retinal Vein Occlusion
Embolism and Thrombosis
Angiogenesis Modulating Agents
Physiological Effects of Drugs