Macular Edema With Central Retinal Vein OcclusionsPhase 4NEWTONNCT01870427
NEWTON: Aflibercept Injection for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions
A Phase 4 study testing Aflibercept (2.0 mg) in people with Macular Edema With Central Retinal Vein Occlusions, run by Northern California Retina Vitreous Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Macular Edema With Central Retinal Vein Occlusions
- What is being tested?
- Aflibercept (2.0 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Retina Vitreous Associates
Mountain View, California, 94040
About this study
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
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.
Read the 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.
- Being tested
- Aflibercept (2.0 mg)
- Keywords
- Macular Edema, Central Retinal Vein Occlusion, CRVO, Aflibercept, VEGF Trap-Eye, Eylea, Ranibizumab, Bevacizumab
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (2.0 mg)Drug
Also called Eylea, VEGF Trap-EYE
Intravitreal Aflibercept (2.0 mg)
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept (2.0 mg) | Experimental | Intravitreal Aflibercept (2.0 mg) Receives: Drug: Aflibercept (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intravitreal Aflibercept on Treatment Interval
Mean number of weeks between each injection where there is no macular edema
Measured: 52 Weeks
Secondary outcomes (4)
Change in Visual Acuity
Mean change in EDTRS BCVA
Measured: 52 Weeks
Retinal Thickness
Mean change in Central Subfoveal Thickness by OCT
Measured: 52 Weeks
Adverse Events
Incidence and severity of ocular and systemic AE's
Measured: 52 Weeks
Number of Treatments
Mean number of Intravitreal Injections
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Macular Edema With Central Retinal Vein OcclusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Retina Vitreous Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Rahul Khurana, M.D., Northern California Retina Vitreous Associates
- Investigators
- Rahul N Khurana, MD, Principal investigator, Northern California Retina Vitreous Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870427
- Sponsor's protocol ID
- NCRVA-2013-Newton-4-01
- Acronym
- NEWTON
- Status last verified
- Dec 2016
- First submitted
- 25 May 2013
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013 Mar;155(3):429-437.e7. doi: 10.1016/j.ajo.2012.09.026. Epub 2012 Dec 4.
PubMed 23218699Boyer D, Heier J, Brown DM, Clark WL, Vitti R, Berliner AJ, Groetzbach G, Zeitz O, Sandbrink R, Zhu X, Beckmann K, Haller JA. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012 May;119(5):1024-32. doi: 10.1016/j.ophtha.2012.01.042. Epub 2012 Mar 21.
PubMed 22440275Heier JS, Campochiaro PA, Yau L, Li Z, Saroj N, Rubio RG, Lai P. Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial. Ophthalmology. 2012 Apr;119(4):802-9. doi: 10.1016/j.ophtha.2011.12.005. Epub 2012 Feb 1.
PubMed 22301066Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29.
PubMed 21715011Khurana RN, Chang LK, Bansal AS, Palmer JD, Wu C, Wieland MR. Treat and extend regimen with aflibercept for chronic central retinal vein occlusions: 2 year results of the NEWTON study. Int J Retina Vitreous. 2019 Apr 15;5:10. doi: 10.1186/s40942-019-0159-x. eCollection 2019.
PubMed 31016030
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01870427
- Acronym / sponsor ID
- NEWTON / NCRVA-2013-Newton-4-01
- Keywords
- Macular Edema, Central Retinal Vein Occlusion, CRVO, Aflibercept, VEGF Trap-Eye, Eylea, Ranibizumab, Bevacizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northern California Retina Vitreous AssociatesUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept (2.0 mg) | Experimental | Drug: Aflibercept (2.0 mg)Intravitreal Aflibercept (2.0 mg) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (2.0 mg)Also: Eylea, VEGF Trap-EYEIntravitreal Aflibercept (2.0 mg) | Drug | Aflibercept (2.0 mg) |
Primary outcome
Duration of Intravitreal Aflibercept on Treatment Interval
Time frame: 52 Weeks
Mean number of weeks between each injection where there is no macular edema
4 secondary outcomes
Change in Visual Acuity
Time frame: 52 Weeks
Retinal Thickness
Time frame: 52 Weeks
Adverse Events
Time frame: 52 Weeks
Number of Treatments
Time frame: 52 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Background: PubMed 23218699Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013 Mar;155(3):429-437.e7. doi: 10.1016/j.ajo.2012.09.026. Epub 2012 Dec 4.
- Background: PubMed 22440275Boyer D, Heier J, Brown DM, Clark WL, Vitti R, Berliner AJ, Groetzbach G, Zeitz O, Sandbrink R, Zhu X, Beckmann K, Haller JA. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012 May;119(5):1024-32. doi: 10.1016/j.ophtha.2012.01.042. Epub 2012 Mar 21.
- Background: PubMed 22301066Heier JS, Campochiaro PA, Yau L, Li Z, Saroj N, Rubio RG, Lai P. Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial. Ophthalmology. 2012 Apr;119(4):802-9. doi: 10.1016/j.ophtha.2011.12.005. Epub 2012 Feb 1.
- Background: PubMed 21715011Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29.
- Derived from this study: PubMed 31016030Khurana RN, Chang LK, Bansal AS, Palmer JD, Wu C, Wieland MR. Treat and extend regimen with aflibercept for chronic central retinal vein occlusions: 2 year results of the NEWTON study. Int J Retina Vitreous. 2019 Apr 15;5:10. doi: 10.1186/s40942-019-0159-x. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul N Khurana, MD principal investigator
Northern California Retina Vitreous Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept (2.0 mg) in people with Macular Edema With Central Retinal Vein Occlusions, run by Northern California Retina Vitreous Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Intravitreal Aflibercept on Treatment Interval (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870427, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.