Retinal Vein OcclusionCRAVENCT01428388
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
A study testing Intravitreal injection of bevacizumab and Intravitreal injection of ranibizumab (0.5 mg per dose) in people with Retinal Vein Occlusion and Macular Edema, run by Barnes Retina Institute at 1 site in United States.
Trial summary
Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- Intravitreal injection of bevacizumab and Intravitreal injection of ranibizumab (0.5 mg per dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD)
- Central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below)
- Diagnosis of retinal vein occlusion in the past 9 months
- Age over 50 years
Who cannot join
- History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit
- Inability to make study visits
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
- Pregnancy or lactation
- Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset
- Any intravitreal injections within 12 weeks of study onset
Show all 9Show fewer
- Prior retinal vein occlusion
- History of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset
- History of cerebrovascular event or myocardial infarction within 3 months of study onset
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- Intravitreal injection of bevacizumab, Intravitreal injection of ranibizumab (0.5 mg per dose)
- Keywords
- macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor
- 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.
Intravitreal injection of bevacizumabDrug
1.25 mg per dose, delivered monthly by intravitreal injection for six months
Intravitreal injection of ranibizumab (0.5 mg per dose)Drug
0.5 mg per dose, delivered monthly by intravitreal injection for six months
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Active comparator | Not described Receives: Drug: Intravitreal injection of bevacizumab |
| Ranibizumab | Active comparator | Not described Receives: Drug: Intravitreal injection of ranibizumab (0.5 mg per dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central retinal thickness
central thickness is measured using optical coherence tomography (OCT)
Measured: six months compared to baseline
Secondary outcomes (2)
change in best-corrected Snellen visual acuity
best-corrected Snellen visual acuity (BCVA) is the best visual acuity measured using a standard Snellen eye chart at 20 feet between (1) uncorrected vision, (2) vision with current eyeglasses or (3) pinholed visual acuity.
Measured: six months compared to baseline
change in fluorescein angiogram
fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.
Measured: six months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Retina Associates of Florida, P.A., Illinois Retina Associates, Kresge Eye Institute, Long Island Vitreoretinal Consultants, Mid Atlantic Retina, Retina Associates, Kansas City, Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Rhonda Weeks, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428388
- Sponsor's protocol ID
- CRAVE1
- Acronym
- CRAVE
- Status last verified
- Oct 2017
- First submitted
- 1 Sep 2011
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rajagopal R, Shah GK, Blinder KJ, Altaweel M, Eliott D, Wee R, Cooper B, Walia H, Smith BT, Joseph DP. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015 Sep;46(8):844-50. doi: 10.3928/23258160-20150909-09.
PubMed 26431300
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01428388
- Acronym / sponsor ID
- CRAVE / CRAVE1
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Keywords
- macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Collaborators
- Retina Associates of Florida, P.A., Illinois Retina Associates, Kresge Eye Institute, Long Island Vitreoretinal Consultants, Mid Atlantic Retina, Retina Associates, Kansas City, Massachusetts Eye and Ear Infirmary
- Study start
- Sep 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Sep 2011 (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.
Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Active comparator | Drug: Intravitreal injection of bevacizumab |
| Ranibizumab | Active comparator | Drug: Intravitreal injection of ranibizumab (0.5 mg per dose) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide informed consent
- Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD)
- Central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below)
- Diagnosis of retinal vein occlusion in the past 9 months
- Age over 50 years
Key exclusion criteria (9 listed)
- History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit
- Inability to make study visits
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
- Pregnancy or lactation
- Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset
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 |
|---|---|---|
| Intravitreal injection of bevacizumab1.25 mg per dose, delivered monthly by intravitreal injection for six months | Drug | Bevacizumab |
| Intravitreal injection of ranibizumab (0.5 mg per dose)0.5 mg per dose, delivered monthly by intravitreal injection for six months | Drug | Ranibizumab |
Primary outcome
change in central retinal thickness
Time frame: six months compared to baseline
central thickness is measured using optical coherence tomography (OCT)
2 secondary outcomes
change in best-corrected Snellen visual acuity
Time frame: six months compared to baseline
change in fluorescein angiogram
Time frame: six months compared to baseline
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 27 Oct 2017.
- Derived from this study: PubMed 26431300Rajagopal R, Shah GK, Blinder KJ, Altaweel M, Eliott D, Wee R, Cooper B, Walia H, Smith BT, Joseph DP. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015 Sep;46(8):844-50. doi: 10.3928/23258160-20150909-09.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal injection of bevacizumab and Intravitreal injection of ranibizumab (0.5 mg per dose) in people with Retinal Vein Occlusion and Macular Edema, run by Barnes Retina Institute 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 9 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 27 Oct 2017. 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.
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?
change in central retinal thickness (time frame: six months compared to baseline). 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 NCT01428388, which also lists 1 linked publication.
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 27 Oct 2017.