Diabetic Macular EdemaPhase 3NCT01823081
Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
A Phase 3 study testing Intravitreal injection of bevacizumab (Avastin) and Intravitreal injection of fasudil and bevacizumab (Avastin) in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Intravitreal injection of bevacizumab (Avastin) and Intravitreal injection of fasudil and bevacizumab (Avastin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients with diabetic macular edema (DME) and:
- Central macula thickness> 250μm
- Visual acuity < 20/40
- No active proliferative diabetic retinopathy
- No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months
Who cannot join
- History of vitrectomy
- History of cataract surgery within the past 6 months
- History of glaucoma or uveitis
- Presence of any macular disorder other than DME
- Presence of traction on the macula
- Significant media opacity
- Serum creatinine>3mg/ml
Trial locations and contacts
1 site in 1 country.
About this study
Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.
Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal injection of bevacizumab (Avastin), Intravitreal injection of fasudil and bevacizumab (Avastin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of bevacizumab (Avastin)Drug
Intravitreal injection of fasudil and bevacizumab (Avastin)Drug
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal bevacizumab (Avastin) | Active comparator | Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks Receives: Drug: Intravitreal injection of bevacizumab (Avastin) |
| Combined intravitreal fasudil and bevacizumab (Avastin) | Active comparator | Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks Receives: Drug: Intravitreal injection of fasudil and bevacizumab (Avastin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Snellen E-chart
Measured: 6 months
central macular thickness
spectral domain optical coherence tomography (SD OCT)
Measured: 6 months
Secondary outcomes (2)
Status of macular perfusion
Heidelberg fluorescein angiogram (HRA II)
Measured: 6 months
intraocular inflammation
clinical examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
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
- NCT01823081
- Sponsor's protocol ID
- 91128
- Status last verified
- Jul 2012
- First submitted
- 21 Mar 2013
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01823081
- Acronym / sponsor ID
- 91128
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2013 (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.
Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.
Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal bevacizumab (Avastin) | Active comparator | Drug: Intravitreal injection of bevacizumab (Avastin)Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks |
| Combined intravitreal fasudil and bevacizumab (Avastin) | Active comparator | Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic patients with diabetic macular edema (DME) and:
- Central macula thickness> 250μm
- Visual acuity < 20/40
- No active proliferative diabetic retinopathy
- No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months
Key exclusion criteria (7 listed)
- History of vitrectomy
- History of cataract surgery within the past 6 months
- History of glaucoma or uveitis
- Presence of any macular disorder other than DME
- Presence of traction on the macula
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 bevacizumab (Avastin) | Drug | Intravitreal bevacizumab (Avastin) |
| Intravitreal injection of fasudil and bevacizumab (Avastin)intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively) | Drug | Combined intravitreal fasudil and bevacizumab (Avastin) |
Primary outcome
Best corrected visual acuity
Time frame: 6 months
Snellen E-chart
central macular thickness
Time frame: 6 months
spectral domain optical coherence tomography (SD OCT)
2 secondary outcomes
Status of macular perfusion
Time frame: 6 months
intraocular inflammation
Time frame: 6 months
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 11 May 2017.
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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 Phase 3 study testing Intravitreal injection of bevacizumab (Avastin) and Intravitreal injection of fasudil and bevacizumab (Avastin) in people with Diabetic 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 5 inclusion and 7 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 11 May 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 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 phase mean?
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?
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?
Best corrected visual acuity (time frame: 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 11 May 2017.