NEWTON: A Single-center Open Label Study Evaluating Intravitreal Aflibercept Injection (IAI) for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions
Overview
- Phase
- Phase 4
- Intervention
- Aflibercept (2.0 mg)
- Conditions
- Macular Edema With Central Retinal Vein Occlusions
- Sponsor
- Northern California Retina Vitreous Associates
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Duration of Intravitreal Aflibercept on Treatment Interval
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Rahul Khurana, M.D.
Principal Investigator
Northern California Retina Vitreous Associates
Eligibility 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)
Arms & Interventions
Aflibercept (2.0 mg)
Intravitreal Aflibercept (2.0 mg)
Intervention: Aflibercept (2.0 mg)
Outcomes
Primary Outcomes
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 Outcomes
- Change in Visual Acuity(52 Weeks)
- Retinal Thickness(52 Weeks)
- Adverse Events(52 Weeks)
- Number of Treatments(52 Weeks)