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Trial record 22 of 81 for:    CRVO - Central Retinal Vein Occlusion

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
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Rahul Khurana, M.D., Northern California Retina Vitreous Associates

Brief Summary:
The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF agents.

Condition or disease Intervention/treatment Phase
Macular Edema With Central Retinal Vein Occlusions Drug: Aflibercept (2.0 mg) Phase 4

Detailed Description:
This prospective, open-label, single-center, nonrandomized, investigator-sponsored clinical study seeks to investigate the visual outcomes of a treat and extend dosing regimen of intravitreal aflibercept injection for macular edema following CRVO. All patients will receive IAI 2 mg at baseline and Week 4. If the pre-defined extension criteria are met at the 4-week visit, and at any follow up visit, the patient will receive a mandated treatment, and the next visit will be extended by two weeks. If the extension criteria are not met on a follow-up visit, the treatment interval will be continued to be reduced by 1 week. If criteria are still not met despite treatment at the reduced interval, treatment will be administered as usual and follow up interval will continue to be reduced by 1 week until the criteria are met or a 4-week interval is reached. Treatment of IAI is rendered at every visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
Drug: Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
Other Names:
  • Eylea
  • VEGF Trap-EYE




Primary Outcome Measures :
  1. Duration of Intravitreal Aflibercept on Treatment Interval [ Time Frame: 52 Weeks ]
    Mean number of weeks between each injection where there is no macular edema


Secondary Outcome Measures :
  1. Change in Visual Acuity [ Time Frame: 52 Weeks ]
    Mean change in EDTRS BCVA

  2. Retinal Thickness [ Time Frame: 52 Weeks ]
    Mean change in Central Subfoveal Thickness by OCT

  3. Adverse Events [ Time Frame: 52 Weeks ]
    Incidence and severity of ocular and systemic AE's

  4. Number of Treatments [ Time Frame: 52 Weeks ]
    Mean number of Intravitreal Injections



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Sponsors and Collaborators
Northern California Retina Vitreous Associates
Regeneron Pharmaceuticals
Investigators
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Principal Investigator: Rahul N Khurana, MD Northern California Retina Vitreous Associates

Publications:
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Responsible Party: Rahul Khurana, M.D., Principal Investigator, Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier: NCT01870427     History of Changes
Other Study ID Numbers: NCRVA-2013-Newton-4-01
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Rahul Khurana, M.D., Northern California Retina Vitreous Associates:
Macular Edema
Central Retinal Vein Occlusion
CRVO
Aflibercept
VEGF Trap-Eye
Eylea
Ranibizumab
Bevacizumab

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases