Anti-VEGF Therapy Versus Dexamethasone Implant for DME
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|ClinicalTrials.gov Identifier: NCT03999125|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clinically Significant Macular Edema Due to Diabetes Mellitus||Drug: Aflibercept, Drug: Ranibizumab Injection Drug: Ozurdex Drug Implant Product||Phase 4|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel, multi-arm trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial|
|Estimated Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||June 24, 2021|
|Estimated Study Completion Date :||June 24, 2023|
Active Comparator: Group 1
Aflibercept intravitreal injection for CSME
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 Intravitreal Injection for CSME
Drug: Ranibizumab Injection
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.
Other Name: Dexamethasone Implant, Aflibercept, Laser
Experimental: Group 3
Dexamethasone Implant for CSME
Drug: Ozurdex Drug Implant Product
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
- Best Corrected Visual Acuity [ Time Frame: 2 years ]BCVA measured at baseline and final follow-up
- Central Subfield Thickness [ Time Frame: 2 years ]Change in CST over 2 years
- Complications [ Time Frame: 2 years ]Complications in each group
- Injection Count [ Time Frame: 2 years ]Number of injections in each group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999125
|Alphavision Augenzentrum||Not yet recruiting|
|Bremerhaven, Bremen, Germany, 27568|
|Contact: Alper Bilgic, MS +491731505937|
|Contact: Aditya Sudhalkar, MS +919909917561|