Clinically Significant Macular Edema Due to Diabetes MellitusPhase 4NCT03999125
Anti-VEGF Therapy Versus Dexamethasone Implant for DME
A Phase 4 study testing Aflibercept,, Ranibizumab Injection and Ozurdex Drug Implant Product in people with Clinically Significant Macular Edema Due to Diabetes Mellitus, run by Sudhalkar Eye Hospital at 1 site in Germany.
Trial summary
We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Clinically Significant Macular Edema Due to Diabetes Mellitus
- What is being tested?
- Aflibercept,, Ranibizumab Injection and Ozurdex Drug Implant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2019to 24 Jun 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
Who cannot join
- Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Alphavision Augenzentrum
Bremerhaven, Free Hanseatic City of Bremen, 27568
Alper Bilgic, MS, +491731505937
Aditya Sudhalkar, MS, +919909917561
About this study
Official title: Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial
We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.
Read the detailed description
A randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients.
Patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion criteria are :
Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
Exclusion Criteria:
Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Refusal for enrolment
A comprehensive ocular and systemic examination will be performed along with fundus fluorescein angiography, optical coherence tomography and intraocular pressure measurements with the Goldmann Applanation Tonometer. The BCVA will be recorded using Snellen's chart
Intravitreal injections will be administered using a standardized technique and under strict asepsis. No postoperative antibiotics will be given.
Patients will be followed on postoperative days 1, 7 and then monthly for 2 years.
At each visit, the BCVA, IOP, ocular exam and OCT scans will be performed at each visit.
Patients will be treated as per the guidelines laid out for the treat and extend study. For the dexamethasone implant, re-injections will be allowed first 3 months after the first injection.
Switch therapy is permissible for anti-VEGF agents after 6 months; first to the other anti-VEGF(for 6 more injections) and then to the dexamethasone implant. Rescue Laser therapy is as per physician's description.
Primary outcome measure: The BCVA in each group from baseline to final follow-up at 2 years.
Secondary outcome measure: Change in CST from baseline to years, the number of injections required per group and the complications, if any.
Statistical Analysis will include demographic descriptions, the Shapiro Wilk test to look for normality of distribution, multiple measures ANOVA test, Fisher's exact test, Chi-Square test and paired and unpaired t-test wherever appropriate.
- Being tested
- Aflibercept,, Ranibizumab Injection, Ozurdex Drug Implant Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept,Drug
Also called Ranibizumab, Dexamethasone Implant, Laser
Primary therapy will be with Aflibercept. If the edema does not respond to the intervention, the patient will be treated with Ranibizumab, Dexamethasone Implant or Laser.
Ranibizumab InjectionDrug
Also called Dexamethasone Implant, Aflibercept, Laser
Primary therapy will be with ranibizumab. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Dexamethasone Implant or Laser.
Ozurdex Drug Implant ProductDrug
Primary therapy will be with Ozurdex. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Ranibizumab or Laser
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Aflibercept intravitreal injection for CSME Receives: Drug: Aflibercept, |
| Group 2 | Other | Ranibizumab Intravitreal Injection for CSME Receives: Drug: Ranibizumab Injection |
| Group 3 | Experimental | Dexamethasone Implant for CSME Receives: Drug: Ozurdex Drug Implant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
BCVA measured at baseline and final follow-up
Measured: 2 years
Secondary outcomes (3)
Central Subfield Thickness
Change in CST over 2 years
Measured: 2 years
Complications
Complications in each group
Measured: 2 years
Injection Count
Number of injections in each group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start25 Jun 2019 (estimated)
- Primary completion24 Jun 2021 (estimated)
- Study completion24 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Significant Macular Edema Due to Diabetes MellitusStudies 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
- Model description
- Parallel, multi-arm trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sudhalkar Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditya Sudhalkar, Sudhalkar Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999125
- Sponsor's protocol ID
- SudhalkarEH
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All details of FFA, OCT, BCVA and IOP
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03999125
- Acronym / sponsor ID
- SudhalkarEH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sudhalkar Eye HospitalUniversity, hospital or other
- Study start
- 25 Jun 2019 (estimated)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 24 Jun 2023 (estimated)
- First posted
- 26 Jun 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.
We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.
Detailed description
A randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients.
Patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion criteria are :
Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
Exclusion Criteria:
Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Refusal for enrolment
A comprehensive ocular and systemic examination will be performed along with fundus fluorescein angiography, optical coherence tomography and intraocular pressure measurements with the Goldmann Applanation Tonometer. The BCVA will be recorded using Snellen's chart
Intravitreal injections will be administered using a standardized technique and under strict asepsis. No postoperative antibiotics will be given.
Patients will be followed on postoperative days 1, 7 and then monthly for 2 years.
At each visit, the BCVA, IOP, ocular exam and OCT scans will be performed at each visit.
Patients will be treated as per the guidelines laid out for the treat and extend study. For the dexamethasone implant, re-injections will be allowed first 3 months after the first injection.
Switch therapy is permissible for anti-VEGF agents after 6 months; first to the other anti-VEGF(for 6 more injections) and then to the dexamethasone implant. Rescue Laser therapy is as per physician's description.
Primary outcome measure: The BCVA in each group from baseline to final follow-up at 2 years.
Secondary outcome measure: Change in CST from baseline to years, the number of injections required per group and the complications, if any.
Statistical Analysis will include demographic descriptions, the Shapiro Wilk test to look for normality of distribution, multiple measures ANOVA test, Fisher's exact test, Chi-Square test and paired and unpaired t-test wherever appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel, multi-arm trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Aflibercept,Aflibercept intravitreal injection for CSME |
| Group 2 | Other | Drug: Ranibizumab InjectionRanibizumab Intravitreal Injection for CSME |
| Group 3 | Experimental | Drug: Ozurdex Drug Implant ProductDexamethasone Implant for CSME |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
Key exclusion criteria (1 listed)
- Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment
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,Also: Ranibizumab, Dexamethasone Implant, LaserPrimary therapy will be with Aflibercept. If the edema does not respond to the intervention, the patient will be treated with Ranibizumab, Dexamethasone Implant or Laser. | Drug | Group 1 |
| Ranibizumab InjectionAlso: Dexamethasone Implant, Aflibercept, LaserPrimary therapy will be with ranibizumab. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Dexamethasone Implant or Laser. | Drug | Group 2 |
| Ozurdex Drug Implant ProductPrimary therapy will be with Ozurdex. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Ranibizumab or Laser | Drug | Group 3 |
Primary outcome
Best Corrected Visual Acuity
Time frame: 2 years
BCVA measured at baseline and final follow-up
3 secondary outcomes
Central Subfield Thickness
Time frame: 2 years
Complications
Time frame: 2 years
Injection Count
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: Yes. All details of FFA, OCT, BCVA and IOP
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.
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,, Ranibizumab Injection and Ozurdex Drug Implant Product in people with Clinically Significant Macular Edema Due to Diabetes Mellitus, run by Sudhalkar Eye Hospital at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 2 years). 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 26 Jun 2019.