Refractory Diabetic Macular EdemaPhase 2/3NCT03821168
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
A Phase 2/3 study testing injection of bevacizumab and erythropoietin and injection of bevacizumab in people with Refractory Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refractory Diabetic Macular Edema
- What is being tested?
- injection of bevacizumab and erythropoietin and injection of bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2019to 1 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient with refractory diabetic macular edema at least one month after third injection
Who cannot join
- previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Morteza Entzari, MD, 009822591616, labbafi@hotmail.com
About this study
after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .
Process of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .
How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.
In the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.
- Conditions
- Refractory Diabetic Macular Edema
- Being tested
- injection of bevacizumab and erythropoietin, injection of bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of bevacizumab and erythropoietinDrug
injection of bevacizumab and erythropoietin
injection of bevacizumabDrug
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
| Study group | Role | What they receive |
|---|---|---|
| intravitreal injection of bevacizumab and erythropoietin | Active comparator | erythropoietin: Receives: Drug: injection of bevacizumab and erythropoietin |
| intravitreal injection of bevacizumab | Active comparator | bevacizumab:1.25 mg Receives: Drug: injection of bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
Snellen chart
Measured: 1 month
Secondary outcomes (1)
Optical coherence tomography
Optical coherence tomography
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
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 Refractory 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 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
- NCT03821168
- Sponsor's protocol ID
- 95287
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Entezari M, Flavarjani ZK, Ramezani A, Nikkhah H, Karimi S, Moghadam HF, Daftarian N, Yaseri M. Combination of intravitreal bevacizumab and erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema: a randomized double-blind clinical trial. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2375-2380. doi: 10.1007/s00417-019-04383-2. Epub 2019 Aug 10.
PubMed 31401683
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03821168
- Acronym / sponsor ID
- 95287
- Conditions
- Refractory Diabetic Macular Edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 29 Jan 2019 (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.
after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .
Process of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .
How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.
In the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravitreal injection of bevacizumab and erythropoietin | Active comparator | Drug: injection of bevacizumab and erythropoietinerythropoietin: |
| intravitreal injection of bevacizumab | Active comparator | Drug: injection of bevacizumabbevacizumab:1.25 mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with refractory diabetic macular edema at least one month after third injection
Key exclusion criteria (1 listed)
- previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage
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 |
|---|---|---|
| injection of bevacizumab and erythropoietininjection of bevacizumab and erythropoietin | Drug | intravitreal injection of bevacizumab and erythropoietin |
| injection of bevacizumabunder gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness | Drug | intravitreal injection of bevacizumab |
Primary outcome
best corrected visual acuity
Time frame: 1 month
Snellen chart
1 secondary outcome
Optical coherence tomography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 31401683Entezari M, Flavarjani ZK, Ramezani A, Nikkhah H, Karimi S, Moghadam HF, Daftarian N, Yaseri M. Combination of intravitreal bevacizumab and erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema: a randomized double-blind clinical trial. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2375-2380. doi: 10.1007/s00417-019-04383-2. Epub 2019 Aug 10.
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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 injection of bevacizumab and erythropoietin and injection of bevacizumab in people with Refractory 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 1 inclusion and 1 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 5 Feb 2019. 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 Morteza Entezari, 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?
best corrected visual acuity (time frame: 1 month). 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 NCT03821168, 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 5 Feb 2019.