FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095221 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two eye injections (Aflibercept and Dexamethasone implant) for patients with vision problems due to diabetes 
Scientific Title of Study   COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL’ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KAUSHALENDRA SINGH  
Designation  PG RESIDENT OPHTHALMOLOGY  
Affiliation  COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA 
Address  DEPARTMENT OF OPHTHALMOLOGY, COMMAND HOSPITAL,EASTERN COMMAND ALIPORE,KOLKATA.

Kolkata
WEST BENGAL
700027
India 
Phone  9906903777  
Fax    
Email  drkaushal9019@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR KAUSHALENDRA SINGH  
Designation  PG RESIDENT OPHTHALMOLOGY  
Affiliation  COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA 
Address  DEPARTMENT OF OPHTHALMOLOGY, COMMAND HOSPITAL,EASTERN COMMAND ALIPORE, KOLKATA.

Kolkata
WEST BENGAL
700027
India 
Phone  9906903777  
Fax    
Email  drkaushal9019@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KAUSHALENDRA SINGH  
Designation  PG RESIDENT OPHTHALMOLOGY  
Affiliation  COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA 
Address  DEPARTMENT OF OPHTHALMOLOGY, COMMAND HOSPITAL,EASTERN COMMAND ALOPORE, KOLKATA.

Kolkata
WEST BENGAL
700027
India 
Phone  9906903777  
Fax    
Email  drkaushal9019@gmail.com  
 
Source of Monetary or Material Support  
Nil  
 
Primary Sponsor  
Name  COMMAND HOSPITAL EASTERN COMMAND KOLKATA 
Address  COMMAND HOSPITAL EASTERN COMMAND KOLKATA ALIPORE KOLKATA 700027 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KAUSHALENDRA SINGH  COMMAND HOSPITAL EASTERN COMMAND KOLKATA   DEPARTMENT OF OPHTHALMOLOGY, COMMAND HOSPITAL,EASTERN COMMAND KOLKATA.
Kolkata
WEST BENGAL 
09906903777

drkaushal9019@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COMMAND HOSPITAL EASTERN COMMAND ALIPORE KOLKATA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL  •Group 1: Aflibercept Arm Intravitreal Aflibercept 2 mg/0.05ml every 4 weeks for 3 loading doses. •Group 2: Dexamethasone Implant Arm A single Intravitreal Dexamethasone implant 0.7 mg  
Comparator Agent  COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL  •Group 2: Dexamethasone Implant Arm a single Intravitreal Dexamethasone implant 0.7 mg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Inclusion Criteria- Male and female patients more than 18 years old with visual impairment due to naive-DME.
Patients with type 1 or type 2 diabetes mellitus and HbA1c of less than 10 percentage at screening
Baseline CST more than 300 µm on spectral-domain OCT.
BCVA between 20/40(6/12) and 20/320(6/96) (ETDRS letters 70 to 25).
Hemoglobin A1c less than 10 percentage
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study
 
 
ExclusionCriteria 
Details  Exclusion criteria
Patients with HbA1C more than 10 mg percentage or those who did not have stable control of diabetes since the last 3 months.
Patients with a history of vitrectomy, cataract leading to poor imaging, intra-ocular surgery within 3 months of enrollment into the study, aphakia, epiretinal membrane, vitreomacular traction.
Patient with uncontrolled hypertension (defined as a systolic blood pressure more than 160 mm Hg or a diastolic blood pressure more than 95 mm Hg)
Patient with history of cerebrovascular accident or myocardial infarction within 6 months, renal failure requiring dialysis or renal transplant, or other retinal vascular diseases
Patient with existing or suspected ocular or periocular infection in the study eye.
Patient with an existing intraocular inflammation (IOI).
Patient with uncontrolled glaucoma (defined as intraocular pressure more than 25 mmHg despite treatment with anti-glaucoma medication,) or according to Investigator’s judgment.
Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye
Use of dexamethasone intravitreal implant (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time.
Laser photocoagulation (focal/grid or pan retinal) in the study eye during the 3-month period prior to baseline
Intraocular surgery including YAG laser in the study eye during the 3-month period prior to baseline
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG pregnancy test
Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
Proliferative diabetic retinopathy requiring Pan retinal photocoagulation (PRP)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intravitreal Aflibercept and intravitreal Dexamethasone implant in improving best-corrected visual acuity (BCVA) in treatment-naive DME patients  Post Operative day-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH  
 
Secondary Outcome  
Outcome  TimePoints 
a)Safety profile (adverse events, intraocular pressure rise, cataract progression).

b)Rescue therapy response rate in non-responders.

c)Change in central macular thickness (CMT) on OCT.

d)Need for additional interventions (repeat dexamethasone, additional anti-VEG, laser)
 
POD-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetic retinopathy. The pathophysiology of DME involves multiple mechanisms, including vascular endothelial growth factor (VEGF) overexpression and chronic inflammation. Two major pharmacologic approaches are widely used for DME management:

 

   Anti-VEGF Therapy (Aflibercept)

          Aflibercept is a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor (PlGF), thereby inhibiting neovascularization and vascular leakage.

 

      It has been established as a first-line therapy for center-involving DME due to its proven efficacy in improving visual acuity (BCVA) and reducing central macular thickness (CMT).


          However, frequent injections (every 4-8 weeks) are required to maintain efficacy, leading to increased treatment burden and patient non-compliance.

 

2      Corticosteroid Therapy (Dexamethasone Implant - Ozurdex)

 

        The dexamethasone intravitreal implant (Ozurdex) provides sustained-release corticosteroid therapy, targeting the inflammatory component of DME. It reduces cytokine-mediated vascular permeability and stabilizes the blood- retinal barrier. Compared to anti-VEGF agents, Ozurdex has a longer duration of action, potentially reducing the number of injections required .However, side effects such as intraocular pressure (IOP) elevation and cataract progression are concerns, especially in phakic patients.

 

        In DME, intravitreal corticosteroids, been traditionally used as second-line     treatment, due to the risk of intraocular pressure increase and cataract-related adverse events.

 

        However, attention has recently been focused on the primary or early use of intravitreal corticosteroids, due to growing evidence of the crucial role of inflammation in the pathogenesis of DME.

 

      Furthermore, intravitreal steroid implants offer the additional advantage of a longer duration of action compared to anti-vascular endothelial growth factor agents (anti-VEGF).

 

 
Close