Clinically Significant Macular EdemaNCT02032238
Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema
A study testing laser photocoagulation in people with Clinically Significant Macular Edema, run by OD-OS GmbH at 1 site in United States.
Trial summary
Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Significant Macular Edema
- What is being tested?
- laser photocoagulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- Phase
- Interventional
- 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
- CSME and Diagnosis of diabetes mellitus
- Able and willing to provide informed consent prior to any study-related procedures
- Central foveal thickness > 250 microns at baseline
- Best corrected visual acuity between 20/400 and 20/40
- Willing and able to comply with clinic visits and study-related procedures
- U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws
Who cannot join
- - Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., macular ischemia, vitreomacular traction, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment.
Show all 23Show fewer
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. 13
- History of YAG capsulotomy performed within 2 months prior to randomization.
- Aphakia.
- Intraocular pressure >= 25 mmHg.
- History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion).
- History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment.
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control)
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry
- Known allergy to any component of the study drug
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization 14
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab.
Read the detailed description
The purpose of this is study is to assess the efficacy of navigated laser treatment in reducing the number of anti-VEGF injections required to maintain visual gain obtained after Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular edema (CSME).
This will be prospective, active-controlled study using Bevacizumab (Genentech, South San Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.
- Conditions
- Clinically Significant Macular Edema
- Being tested
- laser photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser photocoagulationDevice
Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner
| Study group | Role | What they receive |
|---|---|---|
| laser photocoagulation with bevacizumab | Experimental | Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner Receives: Device: laser photocoagulation |
| Bevacizumab, no laser photocoagulation | No intervention | patients receive Anti-VEGF injections (Bevacizumab) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes That Received Retreatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: The number of anticipated participants was not achieved
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.
- Other trials for Clinically Significant Macular EdemaStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- OD-OS GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Weber, Study director, OD-OS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032238
- Sponsor's protocol ID
- CAVNAV-2
- Status last verified
- Jul 2017
- First submitted
- 8 Jan 2014
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema
- ClinicalTrials.gov ID
- NCT02032238
- Acronym / sponsor ID
- CAVNAV-2
- Conditions
- Clinically Significant Macular Edema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of anticipated participants was not achieved
- Enrolment
- 12 participants (actual)
- Lead sponsor
- OD-OS GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab.
Detailed description
The purpose of this is study is to assess the efficacy of navigated laser treatment in reducing the number of anti-VEGF injections required to maintain visual gain obtained after Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular edema (CSME).
This will be prospective, active-controlled study using Bevacizumab (Genentech, South San Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser photocoagulation with bevacizumab | Experimental | Device: laser photocoagulationCombining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner |
| Bevacizumab, no laser photocoagulation | No intervention | –patients receive Anti-VEGF injections (Bevacizumab) only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CSME and Diagnosis of diabetes mellitus
- Able and willing to provide informed consent prior to any study-related procedures
- Central foveal thickness > 250 microns at baseline
- Best corrected visual acuity between 20/400 and 20/40
- Willing and able to comply with clinic visits and study-related procedures
Key exclusion criteria (23 listed)
- - Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., macular ischemia, vitreomacular traction, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
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 |
|---|---|---|
| laser photocoagulationStandard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner | Device | laser photocoagulation with bevacizumab |
Primary outcome
Percentage of Eyes That Received Retreatment
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Ulrike Weber study director
OD-OS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser photocoagulation in people with Clinically Significant Macular Edema, run by OD-OS GmbH 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 6 inclusion and 23 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 11 Aug 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?
Yes. Results are posted in the registry (first posted 11 Aug 2017). 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?
Percentage of Eyes That Received Retreatment (time frame: 12 months). 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 11 Aug 2017.