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出境医 / 临床实验 / Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema
Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema
Study Description
Brief Summary:
Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.
Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema | Device: micropulse laser Drug: Aflibercept | Not Applicable |
Detailed Description:
Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema. One Year Results of a Randomized Clinical Trial |
| Actual Study Start Date : | April 1, 2016 |
| Actual Primary Completion Date : | October 1, 2018 |
| Actual Study Completion Date : | December 1, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Aflibercept plus micropulse laser (group A)
Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).
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Device: micropulse laser
Micropulse session details: Mainster focal grid contact lens (×1.05 laser magnification) was used to perform laser. The 577-nm yellow laser (OcuLight SLx, Iridex Corp., Mountain View, California, USA) was used. Fixed treatment parameters were used in all cases: 200-μm spot size, 200-ms exposure duration, 400-mW power, and a 5% duty cycle. Confluent applications with no spacing were administered using 5x5 grid pattern over the entire edematous area including the fovea. Drug: Aflibercept Aflibercept
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Active Comparator: Aflibercept monotherapy (group B)
Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).
|
Drug: Aflibercept
Aflibercept
|
Outcome Measures
Primary Outcome Measures :
- The number of Aflibercept injections in both groups [ Time Frame: 12 months ]The number of Aflibercept injections in both groups
Secondary Outcome Measures :
- The changes in visual acuity in both groups. [ Time Frame: 12 months ]best corrected visual acuity in both groups at one year.
- The changes in central macular thickness in both groups. [ Time Frame: 12 months ]central macular thickness in both groups at one year
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients were older than 18 with the clinical diagnosis of previously untreated centre involved DME documented by fluorescein angiography and central macular thickness (CMT) ≥ 300 µm on the spectral-domain OCT Best corrected visual acuity was better than 3/60 with Hb A1C less than 10%.
Exclusion Criteria:
- any previous treatment for DME, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on OCT, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 5, 2019 | ||||
| First Posted Date ICMJE | July 10, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Actual Study Start Date ICMJE | April 1, 2016 | ||||
| Actual Primary Completion Date | October 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The number of Aflibercept injections in both groups [ Time Frame: 12 months ] The number of Aflibercept injections in both groups
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema | ||||
| Official Title ICMJE | Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema. One Year Results of a Randomized Clinical Trial | ||||
| Brief Summary |
Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes. Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B). |
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| Detailed Description | Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Diabetic Macular Edema | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
40 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 1, 2018 | ||||
| Actual Primary Completion Date | October 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04014556 | ||||
| Other Study ID Numbers ICMJE | 31181 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mahmoud Abouhussein, University of Alexandria | ||||
| Study Sponsor ICMJE | University of Alexandria | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Alexandria | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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