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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
Sponsor:
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, multi-arm trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Group 1
Aflibercept intravitreal injection for CSME
Drug: 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.
Other Names:
  • Ranibizumab
  • Dexamethasone Implant, Laser

Group 2
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




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: 2 years ]
    BCVA measured at baseline and final follow-up


Secondary Outcome Measures :
  1. Central Subfield Thickness [ Time Frame: 2 years ]
    Change in CST over 2 years

  2. Complications [ Time Frame: 2 years ]
    Complications in each group

  3. Injection Count [ Time Frame: 2 years ]
    Number of injections in each group



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Germany
Alphavision Augenzentrum Not yet recruiting
Bremerhaven, Bremen, Germany, 27568
Contact: Alper Bilgic, MS    +491731505937      
Contact: Aditya Sudhalkar, MS    +919909917561      
Sponsors and Collaborators
Sudhalkar Eye Hospital

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Responsible Party: Aditya Sudhalkar, Consultant Vitreoretinal Surgeon, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT03999125     History of Changes
Other Study ID Numbers: SudhalkarEH
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All details of FFA, OCT, BCVA and IOP
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon completion of study
Access Criteria: Will be provided only to Ophthalmologists

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Ranibizumab
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Immunological