Diabetic Macular EdemaPhase 2/3NCT02772497
3 Month Outcome of Ziv-aflibercept for DME
A Phase 2/3 study testing Ziv aflibercept in people with Diabetic Macular Edema, run by Marashi Eye Clinic.
Trial summary
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ziv aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with central diabetic macular edema
- Best corrected visual acuity is 20/25 or less
- Central macular thickness more than 250 microns
- Patients who are able to come for all follow-up
Who cannot join
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
- History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
About this study
Official title: Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
Read the detailed description
Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective.
Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ziv aflibercept
- Keywords
- DME, Anti VEGF, VEGF trap, Diabetes, Diabetic retinopathy, ZALTRAP, Ziv aflibercept
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziv afliberceptDrug
Also called ZALTRAP
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ziv aflibercept | Experimental | Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks Receives: Drug: Ziv aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of visual acuity improvement using Snellen chart or equivalent
Measured: 3 months
Secondary outcomes (3)
Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
Measured: 3 months
Amount of treatment cost in USD dollars
Measured: 3 months
Number of eyes with retinal toxicity after ziv aflibercept treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marashi Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ameen Marashi, Marashi Eye Clinic
- Investigators
- Ameen Marashi, MD, Principal investigator, Aleppo Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772497
- Sponsor's protocol ID
- Protocol DME1
- Status last verified
- Jul 2017
- First submitted
- 11 May 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02772497
- Acronym / sponsor ID
- Protocol DME1
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, Anti VEGF, VEGF trap, Diabetes, Diabetic retinopathy, ZALTRAP, Ziv aflibercept
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Marashi Eye ClinicUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 May 2016 (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.
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
Detailed description
Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective.
Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ziv aflibercept | Experimental | Drug: Ziv afliberceptIntravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with central diabetic macular edema
- Best corrected visual acuity is 20/25 or less
- Central macular thickness more than 250 microns
- Patients who are able to come for all follow-up
Key exclusion criteria (7 listed)
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
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 |
|---|---|---|
| Ziv afliberceptAlso: ZALTRAPIntravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks | Drug | Ziv aflibercept |
Primary outcome
Proportion of visual acuity improvement using Snellen chart or equivalent
Time frame: 3 months
3 secondary outcomes
Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
Time frame: 3 months
Amount of treatment cost in USD dollars
Time frame: 3 months
Number of eyes with retinal toxicity after ziv aflibercept treatment
Time frame: 3 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 6 Jul 2017.
- Results publicationMarashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114
- Marashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114Link provided by the sponsor.
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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.
Ameen Marashi, MD principal investigator
Aleppo Syria
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ziv aflibercept in people with Diabetic Macular Edema, run by Marashi Eye Clinic.
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 4 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Proportion of visual acuity improvement using Snellen chart or equivalent (time frame: 3 months). 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 NCT02772497, 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 6 Jul 2017.