Diabetes Mellitus, With ComplicationsDMENCT04186702
New Concepts in Diabetic Macular Edema (DME)
A study testing INTRAVITREAL RANIBIZUMAB INJECTION in people with Diabetes Mellitus, With Complications, run by Ain Shams University.
Trial summary
Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, With Complications
- What is being tested?
- INTRAVITREAL RANIBIZUMAB INJECTION
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2014to 9 Sep 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- focal maculopathy
- diffuse macular edema
- diffuse macular edema with ischemic changes
Who cannot join
- ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
- patients with history of stroke or transient ischemic attack
- hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
- evidence of vitreomacular traction (in either eye)
- active proliferative diabetic retinopathy (study eye)
About this study
Official title: New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.
Read the detailed description
Settings and Design: Randomized clinical study
Subjects and Methods:
investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.
- Conditions
- Diabetes Mellitus, With Complications
- Being tested
- INTRAVITREAL RANIBIZUMAB INJECTION
- Keywords
- macula-injection- laser- ranibizumab-edema-thickness
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRAVITREAL RANIBIZUMAB INJECTIONProcedure or surgery
Also called focal/direct argon laser
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
| Study group | Role | What they receive |
|---|---|---|
| visual acuity letter score | Active comparator | visual acuity letter score is used to compare between the two groups after interventional procedures Receives: Procedure: INTRAVITREAL RANIBIZUMAB INJECTION |
| macular thickness(CST) | Active comparator | macular thickness(CST)is used to compare between the two groups after interventional procedures Receives: Procedure: INTRAVITREAL RANIBIZUMAB INJECTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity letter score
The visual acuity letter score at one-year
Measured: one-year follow up
central subfield thickness (CST)
the mean CST observed at one-year
Measured: one-year follow up
Secondary outcomes (1)
patient compliant-complications
subjective symptoms
Measured: one-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Sep 2014
- Primary completion1 Oct 2016
- Study completion9 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, With ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled hamdi elbaklish, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186702
- Sponsor's protocol ID
- FWA000017585 FMASU22/2017
- Acronym
- DME
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data processed and saved in eye center in the college
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
- ClinicalTrials.gov ID
- NCT04186702
- Acronym / sponsor ID
- DME / FWA000017585 FMASU22/2017
- Conditions
- Diabetes Mellitus, With Complications
- Keywords
- macula-injection- laser- ranibizumab-edema-thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 9 Sep 2017 (actual)
- First posted
- 5 Dec 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.
Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.
Detailed description
Settings and Design: Randomized clinical study
Subjects and Methods:
investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- interventional model
| Arm | Type | Receives |
|---|---|---|
| visual acuity letter score | Active comparator | Procedure: INTRAVITREAL RANIBIZUMAB INJECTIONvisual acuity letter score is used to compare between the two groups after interventional procedures |
| macular thickness(CST) | Active comparator | Procedure: INTRAVITREAL RANIBIZUMAB INJECTIONmacular thickness(CST)is used to compare between the two groups after interventional procedures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- focal maculopathy
- diffuse macular edema
- diffuse macular edema with ischemic changes
Key exclusion criteria (6 listed)
- ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
- patients with history of stroke or transient ischemic attack
- hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
- evidence of vitreomacular traction (in either eye)
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 RANIBIZUMAB INJECTIONAlso: focal/direct argon laserinterventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution) | Procedure or surgery | macular thickness(CST), visual acuity letter score |
Primary outcome
visual acuity letter score
Time frame: one-year follow up
The visual acuity letter score at one-year
central subfield thickness (CST)
Time frame: one-year follow up
the mean CST observed at one-year
1 secondary outcome
patient compliant-complications
Time frame: one-year follow up
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 Dec 2019.
- Individual participant dataSharing planned: No. Data processed and saved in eye center in the college
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INTRAVITREAL RANIBIZUMAB INJECTION in people with Diabetes Mellitus, With Complications, run by Ain Shams University.
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 6 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 Dec 2019. 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.
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?
visual acuity letter score (time frame: one-year 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 Dec 2019.