Retinal Vein OcclusionPhase 4NCT01857544
Study of Intravitreal Aflibercept Injection for Persistent CRVO-associated Macular Edema Despite Prior Anti-VEGF Therapy
A Phase 4 study testing Aflibercept in people with Retinal Vein Occlusion, run by Tennessee Retina at 1 site in United States.
Trial summary
The purpose of this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior vitrectomy in the study eye
- Concurrent retinal vascular disease in the study eye that could compromise visual acuity or contribute to macular edema (e.g. diabetic retinopathy, age-related macular degeneration)
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy, advanced glaucoma) that, in the opinion of the investigator, could either
- require medical or surgical intervention during the 6-month study period to prevent or treat visual loss; or,
- if allowed to progress untreated, contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 6 month study period
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
Show all 20Show fewer
- Current vitreous hemorrhage in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline
- Systemic anti-VEGF treatment within the last 3 months prior to screening
- Prior intravitreal aflibercept injection in the study eye
- Macular laser photocoagulation within 4 months of screening
- Intravitreal or periocular corticosteroid within 4 months of screening
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with ocular antihypertensive medication)
- Allergy to fluorescein, povidone iodine (Betadine) or aflibercept
- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
- Patients with cognitive dysfunction such as dementia, Alzheimer's disease or any other neuro-degenerative disorder.
- 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; 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. **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.
About this study
Official title: Phase 4 Study of Intravitreal Aflibercept Injection for Recalcitrant Central Retinal Vein Occlusion Associated Macular Edema Despite Prior Anti-Vascular Endothelial Growth Factor (VEGF) Therapy. (ARChiMEDES)
The purpose of this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept.
Read the detailed description
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 6 months. All subjects will receive monthly 2.0 mg intravitreal aflibercept injections.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Aflibercept
- Keywords
- Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called VEGF-Trap, Eylea
Monthly 2.0mg Aflibercept Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept 2.0mg | Experimental | Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT)
Measured: From baseline to Month 6
Secondary outcomes (5)
Extent of reduction in macular thickness
Measured: Month 6
Extent of reduction in macular volume
Measured: Month 6
Mean change in best-corrected visual acuity (BCVA)
Measured: Month 6
Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA
Measured: Month 6
Number and severity of adverse events
Measured: 6 month-period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tennessee Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Franco M Recchia, MD, Principal investigator, Tennessee Retina, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857544
- Sponsor's protocol ID
- VGFT-OD-1313
- Other IDs
- VGFT-OD-1313
- Status last verified
- Oct 2014
- First submitted
- 16 May 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Intravitreal Aflibercept Injection for Recalcitrant Central Retinal Vein Occlusion Associated Macular Edema Despite Prior Anti-Vascular Endothelial Growth Factor (VEGF) Therapy. (ARChiMEDES)
- ClinicalTrials.gov ID
- NCT01857544
- Acronym / sponsor ID
- VGFT-OD-1313
- Conditions
- Retinal Vein Occlusion
- Keywords
- Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tennessee RetinaUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 May 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 this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept.
Detailed description
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 6 months. All subjects will receive monthly 2.0 mg intravitreal aflibercept injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept 2.0mg | Experimental | Drug: AfliberceptSingle arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Prior vitrectomy in the study eye
- Concurrent retinal vascular disease in the study eye that could compromise visual acuity or contribute to macular edema (e.g. diabetic retinopathy, age-related macular degeneration)
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy, advanced glaucoma) that, in the opinion of the investigator, could either
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
- Current 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 |
|---|---|---|
| AfliberceptAlso: VEGF-Trap, EyleaMonthly 2.0mg Aflibercept Intravitreal Injection | Drug | Aflibercept 2.0mg |
Primary outcome
Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT)
Time frame: From baseline to Month 6
5 secondary outcomes
Extent of reduction in macular thickness
Time frame: Month 6
Extent of reduction in macular volume
Time frame: Month 6
Mean change in best-corrected visual acuity (BCVA)
Time frame: Month 6
Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA
Time frame: Month 6
Number and severity of adverse events
Time frame: 6 month-period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Related trials for Retinal Vein Occlusion
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
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.
Franco M Recchia, MD principal investigator
Tennessee Retina, PC
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 in people with Retinal Vein Occlusion, run by Tennessee Retina 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 0 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. 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?
Results are not available in the source record.
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?
Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT) (time frame: From baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2014.