Retinal Vein OcclusionPhase 4NCT04707625
Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
A Phase 4 study testing Aflibercept Ophthalmic in people with Retinal Vein Occlusion, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. 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 Ophthalmic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 18 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Willingness and ability to provide written informed consent.
- Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography
- Visual Acuity between 20/25 and 5/200
Who cannot join
- Bilateral Retinal Vein Occlusion
- Vision worse than 5/200 in study eye
- History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening
- Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy
- Concurrent Exudative Age-related Macular Degeneration
- Concurrent optic neuropathy with the presence of an afferent pupillary defect
Show all 11Show fewer
- Previous vitrectomy in the study eye
- Currently pregnant or planning to become pregnant during the duration of the study. Women currently breastfeeding are also excluded.
- Previous treatment for retinal vein occlusion in the study eye
- Any current medical condition which, in the opinion of the investigator is considered to be uncontrolled
- History of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Correlation of Vascular Endothelial Growth Factor Levels in Anterior Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving Standard of Care Treatment
The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.
Read the detailed description
Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Aflibercept Ophthalmic
- Keywords
- Vision Loss, Eye Injections
- Medical subject headings
- Retinal Vein Occlusion, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept OphthalmicDrug
Also called Eylea
Anti-vascular endothelial growth factor intraocular injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Other | All subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks. Receives: Drug: Aflibercept Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Macular Edema
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Measured: Baseline through week 35
Change in Macular Volume
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Measured: Baseline through week 35
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis
Measured: Baseline through week 35
Secondary outcomes (9)
Change in Best Corrected Visual Acuity (BCVA)
Using Snellen Visual Acuity charts - The results are based on what line the patient can read with ease - If a subject's visual acuity is so poor that the subject can't see any letters on the charts, finger counting and/or hand motions will be checked
Measured: Baseline through week 35
Change in Intraocular Pressure (IOP)
Evaluated by tonometry - Tonometry is the procedure eye care professionals perform to determine the intraocular pressure (IOP), the fluid pressure inside the eye - Most tonometers are calibrated to measure pressure in millimeters of mercury (mmHg)
Measured: Baseline through week 52
Number of Intravitreal Injections
Number of injections received during study participation
Measured: Baseline through week 52
Change in Analytes - Chemokine (C-C Motif) Ligand (CCL)s
Chemokine (C-C motif) ligand 2 (CCL2)/(JE/MCP-1) Monocyte chemoattractant protein 1 and C-C motif chemokine 11(CCL11)/Eotaxin - Analyzed using an ELISA multiplex
Measured: Baseline through week 52
Change in Analytes - Chemokine (C-X-C Motif) Ligand (CXCL)s
CXCL1/GRO alpha/KC/Cytokine-induced neutrophil chemoattractant (CINC-1) and CXCL2/GRO beta/MIP-s/CINC-3 - Analyzed using an ELISA multiplex
Measured: Baseline through week 52
Change in Analytes - Growth Factors
Epidermal growth factor (EGF) and basic fibroblast growth factor (FGF basic)/FGF2/bFGF - and Transforming growth factor alpha (TGF-alpha) - and Platelet-derived growth factor (PDGF)-AA and PDGF-AB/BBA analyzed using an ELISA multiplex Analyzed
Measured: Baseline through week 52
Change in Analytes - Interferons
Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex
Measured: Baseline through week 52
Change in Analytes - Proteins
Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex
Measured: Baseline through week 52
Change in Analytes - Interleukins
IL-1 alpha/IL-1F1
- IL-1 beta/IL-1F2
- IL-1ra/IL-1F3
- IL-2
- IL-3
- IL-4
- IL-5
- IL-6
- IL-7
- IL-8/CXCL8
- IL-10
- IL-12 p70
- IL-13
- IL-15
- IL-17/IL-17A
- IL-17E/IL-25
- IL-33 Analyzed using an ELISA multiplex
Measured: Baseline through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start6 Oct 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Why it stopped: IRB stopped study due to safety concerns. No further data collection and what has been collected is not appropriate for analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive the same standard of care treatment.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707625
- Sponsor's protocol ID
- IRB00064405
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2021
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this time.
Publications
Clark WL, Boyer DS, Heier JS, Brown DM, Haller JA, Vitti R, Kazmi H, Berliner AJ, Erickson K, Chu KW, Soo Y, Cheng Y, Campochiaro PA. Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results of the VIBRANT Study. Ophthalmology. 2016 Feb;123(2):330-336. doi: 10.1016/j.ophtha.2015.09.035. Epub 2015 Oct 30.
PubMed 26522708Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.
PubMed 25068637Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27.
PubMed 24679444Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.
PubMed 23722722
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Vascular Endothelial Growth Factor Levels in Anterior Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving Standard of Care Treatment
- ClinicalTrials.gov ID
- NCT04707625
- Acronym / sponsor ID
- IRB00064405
- Conditions
- Retinal Vein Occlusion
- Keywords
- Vision Loss, Eye Injections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB stopped study due to safety concerns. No further data collection and what has been collected is not appropriate for analysis.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 24 Feb 2025
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 to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.
Detailed description
Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive the same standard of care treatment.
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Other | Drug: Aflibercept OphthalmicAll subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness and ability to provide written informed consent.
- Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography
- Visual Acuity between 20/25 and 5/200
Key exclusion criteria (11 listed)
- Bilateral Retinal Vein Occlusion
- Vision worse than 5/200 in study eye
- History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening
- Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy
- Concurrent Exudative Age-related Macular Degeneration
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 OphthalmicAlso: EyleaAnti-vascular endothelial growth factor intraocular injection | Drug | Aflibercept |
Primary outcome
Change in Macular Edema
Time frame: Baseline through week 35
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Macular Volume
Time frame: Baseline through week 35
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber
Time frame: Baseline through week 35
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis
9 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline through week 35
Change in Intraocular Pressure (IOP)
Time frame: Baseline through week 52
Number of Intravitreal Injections
Time frame: Baseline through week 52
Change in Analytes - Chemokine (C-C Motif) Ligand (CCL)s
Time frame: Baseline through week 52
Change in Analytes - Chemokine (C-X-C Motif) Ligand (CXCL)s
Time frame: Baseline through week 52
Change in Analytes - Growth Factors
Time frame: Baseline through week 52
Change in Analytes - Interferons
Time frame: Baseline through week 52
Change in Analytes - Proteins
Time frame: Baseline through week 52
Change in Analytes - Interleukins
Time frame: Baseline through week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26522708Clark WL, Boyer DS, Heier JS, Brown DM, Haller JA, Vitti R, Kazmi H, Berliner AJ, Erickson K, Chu KW, Soo Y, Cheng Y, Campochiaro PA. Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results of the VIBRANT Study. Ophthalmology. 2016 Feb;123(2):330-336. doi: 10.1016/j.ophtha.2015.09.035. Epub 2015 Oct 30.
- Background: PubMed 25068637Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.
- Background: PubMed 24679444Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27.
- Background: PubMed 23722722Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.
- Eyla prescribing informationLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
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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.
Mark Nelson, MD principal investigator
Wake Forest University Health Sciences
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 Ophthalmic in people with Retinal Vein Occlusion, run by Wake Forest University Health Sciences 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Macular Edema (time frame: Baseline through week 35). The study lists 3 primary outcomes in all. 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 NCT04707625, which also lists 4 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 24 Feb 2025.