Central Retinal Vein OcclusionNCT04601701
Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
A study testing Bevacizumab Ophthalmic and Intravitreal Dexamethasone. and Bevacizumab Ophthalmic. in people with Central Retinal Vein Occlusion, run by He Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Bevacizumab Ophthalmic and Intravitreal Dexamethasone. and Bevacizumab Ophthalmic.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2020to 17 Sep 2021
- Phase
- Interventional
- 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
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to CRVO
- BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Who cannot join
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- Neovascularization of the iris or neovascular glaucoma in the study eye
Show all 11Show fewer
- Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
- Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
- Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
- Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
He Eye Specialist Hospital
Shenyang, Liaoning, 110001
Jun Li, M.D., Ph.D., 0086-411-86525401, robin_lijun@sina.com
Emmanuel E Pazo, M.D., Ph.D., 008618612782131, ericpazo@outlook.com
About this study
Official title: Study on Central Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
The purpose of this study is to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone.
Read the detailed description
Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO.
Bevacizumab, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Bevacizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.
Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Bevacizumab Ophthalmic and Intravitreal Dexamethasone., Bevacizumab Ophthalmic.
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Ophthalmic and Intravitreal Dexamethasone.Drug
Also called Avastin®, Ozurdex®
Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
Bevacizumab Ophthalmic.Drug
Also called Avastin®
Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
| Study group | Role | What they receive |
|---|---|---|
| CRVO: Bevacizumab and intravitreal Dexamethasone. | Experimental | Participants with CRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. Receives: Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone. |
| CRVO: Bevacizumab | Active comparator | Participants with CRVO will receive a combination of Bevacizumab only. Receives: Drug: Bevacizumab Ophthalmic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in monocular BCVA in the treatment eye
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary outcomes (11)
Mean change in central subfield retinal thickness
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT).
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Number of Ranibizumab Treatments
Number of injections provided to the patients during the 6 month period.
Measured: Day 1 through Month 6
Mean change in NEI VFQ25 Questionnaire Score
Scores from NEI VFQ25 questionnaire will be assessed and compared
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire will be assessed and compared
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Measured: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Use of additional treatments (including laser) is assessed by the treating ophthalmologist
Measured: Day 1 through Month 6
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start17 Oct 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion17 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei He, M.D., Ph.D., Study chair, He Eye Specialist Hospital, Shenyang.Jun Li, M.D., Ph.D., Principal investigator, He Eye Specialist Hospital, Shenyang.Emmanuel E Pazo, M.D., Ph.D., Study director, He Eye Specialist Hospital, Shenyang.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601701
- Sponsor's protocol ID
- ME-270620
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Central Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
- ClinicalTrials.gov ID
- NCT04601701
- Acronym / sponsor ID
- ME-270620
- Conditions
- Central Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 17 Sep 2021 (estimated)
- First posted
- 26 Oct 2020 (actual)
- 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 to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone.
Detailed description
Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO.
Bevacizumab, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Bevacizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.
Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRVO: Bevacizumab and intravitreal Dexamethasone. | Experimental | Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone.Participants with CRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. |
| CRVO: Bevacizumab | Active comparator | Drug: Bevacizumab Ophthalmic.Participants with CRVO will receive a combination of Bevacizumab only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to CRVO
- BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Key exclusion criteria (11 listed)
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either 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 |
|---|---|---|
| Bevacizumab Ophthalmic and Intravitreal Dexamethasone.Also: Avastin®, Ozurdex®Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected. | Drug | CRVO: Bevacizumab and intravitreal Dexamethasone. |
| Bevacizumab Ophthalmic.Also: Avastin®Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected. | Drug | CRVO: Bevacizumab |
Primary outcome
Mean change in monocular BCVA in the treatment eye
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters.
Mean change in binocular BCVA
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters.
11 secondary outcomes
Mean change in central subfield retinal thickness
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Number of Ranibizumab Treatments
Time frame: Day 1 through Month 6
Mean change in NEI VFQ25 Questionnaire Score
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Time frame: Day 1 through Month 6
People meeting driving standards
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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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.
Wei He, M.D., Ph.D. study chair
He Eye Specialist Hospital, Shenyang.
Jun Li, M.D., Ph.D. principal investigator
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo, M.D., Ph.D. study director
He Eye Specialist Hospital, Shenyang.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab Ophthalmic and Intravitreal Dexamethasone. and Bevacizumab Ophthalmic. in people with Central Retinal Vein Occlusion, run by He Eye Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. 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 China. 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.
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?
Contact Jun Li, M.D., Ph.D. (0086-411-86525401, robin_lijun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in monocular BCVA in the treatment eye (time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.). The study lists 2 primary outcomes in all. 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 26 Oct 2020.