Diabetic Macular EdemaPhase 4MPLNCT03866746
Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema
A Phase 4 study testing Aflibercept Injection and micropulsed yellow laser in people with Diabetic Macular Edema, run by Al Hadi Hospital at 1 site in Kuwait.
Trial summary
prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Aflibercept Injection and micropulsed yellow laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteKuwait
- Study dates
- 8 May 2017to 28 Dec 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years old
- diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
- best corrected visual acuity (BCVA) between 20/400 and 20/40.
Who cannot join
- patients with intra-ocular surgery as cataract surgery within 6 months
- prior intravitreal injection of any drug within the preceding 6 months
- panretinal photocoagulation (PRP) within the former 4 months.
- Patients with previous macular laser
- patients with vitreo-macular traction (VMT) syndrome
- severe glaucoma
- other retinal vascular diseases
- conditions that impede the OCT interpretation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Aflibercept Injection, micropulsed yellow laser
- Keywords
- Aflibercept, Anti-VEGFs, micropulsed diode laser, subthreshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept InjectionDrug
Also called Micropulsed yellow laser
Group A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A.
micropulsed yellow laserOther
Micropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | received aflibercept injections alone Receives: Drug: Aflibercept Injection |
| Group B | Experimental | received 3 aflibercept injections followed by micropulsed laser Receives: Drug: Aflibercept Injection; Other: micropulsed yellow laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of intravitreal injections
the total number of intravitreal aflibercept injections were recorded
Measured: 18th month follow-up.
Central macular thickness
in um
Measured: 18 month
Secondary outcomes (1)
best corrected visual acuity measured in ETDRS.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start8 May 2017
- Primary completion21 Jun 2017
- Study completion28 Dec 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Hadi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer MohamedSadeck Khattab, Al Hadi Hospital
- Investigators
- Abeer M Khattab, MD, Principal investigator, Al Hadi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866746
- Sponsor's protocol ID
- AlHadi Hospital
- Acronym
- MPL
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2019
- Last updated
- 5 Jul 2019
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
- ClinicalTrials.gov ID
- NCT03866746
- Acronym / sponsor ID
- MPL / AlHadi Hospital
- Conditions
- Diabetic Macular Edema
- Keywords
- Aflibercept, Anti-VEGFs, micropulsed diode laser, subthreshold
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Al Hadi HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 7 Mar 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.
prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Aflibercept Injectionreceived aflibercept injections alone |
| Group B | Experimental | Drug: Aflibercept Injection, Other: micropulsed yellow laserreceived 3 aflibercept injections followed by micropulsed laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years old
- diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
- best corrected visual acuity (BCVA) between 20/400 and 20/40.
Key exclusion criteria (8 listed)
- patients with intra-ocular surgery as cataract surgery within 6 months
- prior intravitreal injection of any drug within the preceding 6 months
- panretinal photocoagulation (PRP) within the former 4 months.
- Patients with previous macular laser
- patients with vitreo-macular traction (VMT) syndrome
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 |
|---|---|---|
| Aflibercept InjectionAlso: Micropulsed yellow laserGroup A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A. | Drug | Group A, Group B |
| micropulsed yellow laserMicropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction. | Other | Group B |
Primary outcome
the number of intravitreal injections
Time frame: 18th month follow-up.
the total number of intravitreal aflibercept injections were recorded
Central macular thickness
Time frame: 18 month
in um
1 secondary outcome
best corrected visual acuity measured in ETDRS.
Time frame: 18 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 5 Jul 2019.
- 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.
Abeer M Khattab, MD principal investigator
Al Hadi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept Injection and micropulsed yellow laser in people with Diabetic Macular Edema, run by Al Hadi Hospital at 1 site in Kuwait.
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 3 inclusion and 8 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 5 Jul 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 Kuwait. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the number of intravitreal injections (time frame: 18th month follow-up.). 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 5 Jul 2019.