Anti-VEGF Therapy Versus Dexamethasone Implant for DME

NCT ID: NCT03999125

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2023-06-24

Brief 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.

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.

Conditions

Clinically Significant Macular Edema Due to Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Aflibercept intravitreal injection for CSME

Group Type: ACTIVE_COMPARATOR

Aflibercept,

Intervention Type: DRUG

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.

Group 2

Ranibizumab Intravitreal Injection for CSME

Group Type: OTHER

Ranibizumab Injection

Intervention Type: DRUG

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.

Group 3

Dexamethasone Implant for CSME

Group Type: EXPERIMENTAL

Ozurdex Drug Implant Product

Intervention Type: DRUG

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

Interventions

Aflibercept,

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Ranibizumab; Dexamethasone Implant, Laser; Dexamethasone Implant, Aflibercept, Laser

Eligibility Criteria

Inclusion Criteria

• 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) Macular ischemia or proliferative Disease Refusal for enrolment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sudhalkar Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aditya Sudhalkar

Consultant Vitreoretinal Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alphavision Augenzentrum

Bremerhaven, City state Bremen, Germany

Countries

Germany

Facility Contacts

Alper Bilgic, MS

Role: primary

+491731505937

Aditya Sudhalkar, MS

Role: backup

+919909917561

Other Identifiers

SudhalkarEH

Identifier Type: -

Identifier Source: org_study_id