Retinal Vein Occlusion With Macular EdemaPhase 2/3bevacizumabNCT03353324
Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
A Phase 2/3 study testing intravitreal injection of bevacizumab and intravitreal injection of bevacizumab+ targeted laser in people with Retinal Vein Occlusion With Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Vein Occlusion With Macular Edema
- What is being tested?
- intravitreal injection of bevacizumab and intravitreal injection of bevacizumab+ targeted laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2017to Sep 2018
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Center-involved macular edema secondary to RVO on clinical exam
- Symptoms less than 3 months
- BCVA= 20/40 or worse
- Mean center point thickness >250 μm
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
- One eye per participant is enrolled in the trial
Who cannot join
- Macular edema due to a cause other than CRVO
- An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- Prior treatment with intravitreal or peribulbar steroid injection
- History of macular photocoagulation or PRP
- Prior pars plana vitrectomy
Show all 9Show fewer
- Hx of Intraocular surgery (including cataract extraction)
- uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
- vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
alireaza ramezani, MD, 009822591616, labbafi@hotmail.com
About this study
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
- Being tested
- intravitreal injection of bevacizumab, intravitreal injection of bevacizumab+ targeted laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of bevacizumabDrug
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months.
intravitreal injection of bevacizumab+ targeted laserRadiation
patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared
| Study group | Role | What they receive |
|---|---|---|
| intravitreal injection of bevacizumab | Active comparator | Not described Receives: Drug: intravitreal injection of bevacizumab |
| intravitreal injection of bevacizumab+ targeted laser | Active comparator | Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas Receives: Radiation: intravitreal injection of bevacizumab+ targeted laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Snellen chart
Measured: Every month
Secondary outcomes (1)
macular thickness
OCT
Measured: every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Nov 2017
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein Occlusion With 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353324
- Sponsor's protocol ID
- 9696
- Acronym
- bevacizumab
- Status last verified
- May 2017
- First submitted
- 21 Nov 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT03353324
- Acronym / sponsor ID
- bevacizumab / 9696
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Nov 2017 (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.
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravitreal injection of bevacizumab | Active comparator | Drug: intravitreal injection of bevacizumab |
| intravitreal injection of bevacizumab+ targeted laser | Active comparator | Radiation: intravitreal injection of bevacizumab+ targeted laserIntervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Center-involved macular edema secondary to RVO on clinical exam
- Symptoms less than 3 months
- BCVA= 20/40 or worse
- Mean center point thickness >250 μm
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
Key exclusion criteria (9 listed)
- Macular edema due to a cause other than CRVO
- An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- Prior treatment with intravitreal or peribulbar steroid injection
- History of macular photocoagulation or PRP
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 bevacizumabunder gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months. | Drug | intravitreal injection of bevacizumab |
| intravitreal injection of bevacizumab+ targeted laserpatients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging . After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared | Radiation | intravitreal injection of bevacizumab+ targeted laser |
Primary outcome
Visual acuity
Time frame: Every month
Snellen chart
1 secondary outcome
macular thickness
Time frame: every month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intravitreal injection of bevacizumab and intravitreal injection of bevacizumab+ targeted laser in people with Retinal Vein Occlusion With Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 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: status not confirmed, as of the sponsor's last update on 31 May 2018. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Alireza Ramezani, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Every month). 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 31 May 2018.