Anti-VEGF Therapy Versus Dexamethasone Implant for DME

NCT03999125 | Unknown Phase 4

• 1 other identifier: SudhalkarEH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinically Significant Macular Edema Due to Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  BCVA measured at baseline and final follow-up

  2 years

Secondary Outcomes (3)

• Central Subfield Thickness

  2 years

• Complications

  2 years

• Injection Count

  2 years

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Aflibercept intravitreal injection for CSME

Drug: Aflibercept,

Group 2

OTHER

Ranibizumab Intravitreal Injection for CSME

Drug: Ranibizumab Injection

Group 3

EXPERIMENTAL

Dexamethasone Implant for CSME

Drug: Ozurdex Drug Implant Product

Interventions

Aflibercept, 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.

Also known as: Ranibizumab, Dexamethasone Implant, Laser

Group 1

Ranibizumab Injection 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.

Also known as: Dexamethasone Implant, Aflibercept, Laser

Group 2

Ozurdex Drug Implant Product 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

Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Well controlled diabetes(HbA1c\<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA \< or equal to 6/12.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudhalkar Eye Hospital: lead

Study Sites (1)

Alphavision Augenzentrum

Bremerhaven, City state Bremen, 27568, Germany

Location

MeSH Terms

Interventions

aflibercept; Ranibizumab; Dexamethasone; Lasers

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Vitreoretinal Surgeon

Model Details: Parallel, multi-arm trial

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: June 25, 2019
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2023
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon completion of study
• Access Criteria: Will be provided only to Ophthalmologists

Locations

DE (1)