Diabetic Macular EdemaPhase 3NCT05271539
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
A Phase 3 study testing Lucentis alone group and Lucentis dexamethasone group in people with Diabetic Macular Edema, run by Cairo University at 1 site in Egypt.
Trial summary
Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Lucentis alone group and Lucentis dexamethasone group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 15 Sep 2021
- Phase
- Phase 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography [OCT]).
- Best corrected visual acuity of 6/12 or less.
Who cannot join
- ● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
- History of panretinal photocoagulation within the last 6 months.
- PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
- Macular ischemia, as indicated with Fluorescein Angiography.
- Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
- Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
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- Vitreomacular traction syndrome.
- Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
- Glaucoma, whether suspected or confirmed.
- Significant media opacity.
- Patients with ocular or periocular infections, or infection in the other eye
- Signs of Active or resolved uveitis and intraocular inflammation.
- Bad diabetic control as indicated by HbA1C >8.
- Renal impairment, hepatic impairment, or congestive heart failure.
- History of cardiovascular insult or stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Efficacy of Intravitreal Ranibizumab Versus Its Combination With Commercial Dexamethasone in The Treatment of Diabetic Macular Edema
Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.
Read the detailed description
This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.
Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.
Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.
Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.
. The number of injections needed to achieve the same effect on CMT and BCVA.
- Conditions
- Diabetic Macular Edema
- Being tested
- Lucentis alone group, Lucentis dexamethasone group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucentis alone groupDrug
The Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns
Lucentis dexamethasone groupDrug
Lucentis dexamethasone group received intravitreal injections of combination of both lucentis and commercial dexamethasone. the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Treatment was stopped when CMT improved below 250 µ.
| Study group | Role | What they receive |
|---|---|---|
| The first group, Lucentis alone group | Active comparator | The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. Receives: Drug: Lucentis alone group |
| The second group, Lucentis dexamethasone group | Active comparator | The second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Receives: Drug: Lucentis dexamethasone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central foveal thickness
Central foveal thickness in microns measured by OCT
Measured: 6 months after the first injection
BCVA (Decimal)
Best corrected visual acuity measured on Snellen chart in Decimal form
Measured: 6 months after the first injection
The number of injections
The total number of injections in each Arm group
Measured: over 6 months duration of the study
Secondary outcomes (1)
IOP
Intraocular pressure
Measured: 6 months after the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion15 Sep 2021
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.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. While the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled gamal abueleinen, Cairo University
- Investigators
- Khaled G Abueleinen, MD, PhD, Principal investigator, Ophthalmology department, Faculty of Medicine Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271539
- Sponsor's protocol ID
- MS-278-2020
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.
PubMed 29127949
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Intravitreal Ranibizumab Versus Its Combination With Commercial Dexamethasone in The Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05271539
- Acronym / sponsor ID
- MS-278-2020
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 9 Mar 2022 (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 alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.
Detailed description
This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.
Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.
Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.
Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.
. The number of injections needed to achieve the same effect on CMT and BCVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. While the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).
| Arm | Type | Receives |
|---|---|---|
| The first group, Lucentis alone group | Active comparator | Drug: Lucentis alone groupThe first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. |
| The second group, Lucentis dexamethasone group | Active comparator | Drug: Lucentis dexamethasone groupThe second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography [OCT]).
- Best corrected visual acuity of 6/12 or less.
Key exclusion criteria (15 listed)
- ● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
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 |
|---|---|---|
| Lucentis alone groupThe Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns | Drug | The first group, Lucentis alone group |
| Lucentis dexamethasone groupLucentis dexamethasone group received intravitreal injections of combination of both lucentis and commercial dexamethasone. the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Treatment was stopped when CMT improved below 250 µ. | Drug | The second group, Lucentis dexamethasone group |
Primary outcome
Central foveal thickness
Time frame: 6 months after the first injection
Central foveal thickness in microns measured by OCT
BCVA (Decimal)
Time frame: 6 months after the first injection
Best corrected visual acuity measured on Snellen chart in Decimal form
The number of injections
Time frame: over 6 months duration of the study
The total number of injections in each Arm group
1 secondary outcome
IOP
Time frame: 6 months after the first injection
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 9 Mar 2022.
- Background: PubMed 29127949Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.
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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.
Khaled G Abueleinen, MD, PhD principal investigator
Ophthalmology department, Faculty of Medicine Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lucentis alone group and Lucentis dexamethasone group in people with Diabetic Macular Edema, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 15 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 9 Mar 2022. 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 Egypt. 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 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?
Central foveal thickness (time frame: 6 months after the first injection). The study lists 3 primary outcomes in all. 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 NCT05271539, 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 9 Mar 2022.