| CTRI Number |
CTRI/2025/09/094271 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing the Cost and Benefits of Anti-VEGF Injections in Patients with Diabetic Macular Edema in India |
|
Scientific Title of Study
|
Economic Impact and Patient Outcomes of Anti-VEGF Therapy in Diabetic Macular Edema: A Comparative Cost Analysis in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shourya Vardhan Azad |
AIIMS, Delhi |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
South
DELHI |
9990026277
shoryaazad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-VEGF Cost-Effective Therapy |
Drug: Bevacizumab
Route: Intravitreal injection
Dosage Regimen: 1.25 mg Bevacizumab intravitreally
Frequency: Monthly for first 3 months (loading phase), followed by Pro Re Nata (PRN) / treat-and-extend regimen, based on physician’s discretion
Duration: 12 months |
| Intervention |
Anti-VEGF Standard Therapy |
Drug: Ranibizumab or Aflibercept (as per hospital protocol)
Route: Intravitreal injection
Dosage Regimen: 0.5 mg Ranibizumab / 2 mg Aflibercept intravitreally
Frequency: Monthly for first 3 months (loading phase), followed by Pro Re Nata (PRN) / treat-and-extend regimen, based on physician’s discretion
Duration: 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with center-involving diabetic macular edema (CI-DME) confirmed by optical coherence tomography (OCT).
2.Age more than 18 years at the time of first treatment.
3.Received anti-VEGF therapy (Ranibizumab, Aflibercept, or Bevacizumab) between January 2018 and March 2025 at Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi.
4.Minimum follow-up duration of 6 months post initial anti-VEGF injection.
5.Availability of complete clinical records including:
a.Best-corrected visual acuity (BCVA)
b.Central retinal thickness (CRT)
c.Cost data (direct and indirect)
6.Patients who have provided general consent for retrospective use of data or where waiver of consent is approved by the ethics committee. |
|
| ExclusionCriteria |
| Details |
1.Eyes with prior vitreoretinal surgery or any intraocular surgery (except uncomplicated cataract surgery) within 6 months before anti-VEGF initiation.
2.Co-existing ocular diseases affecting vision (e.g., age-related macular degeneration, retinal vein occlusion, advanced glaucoma).
3.Patients who received combination therapy (e.g., anti-VEGF + steroid or laser) during the study period (unless separate groups are analyzed).
4.Inadequate imaging or clinical data preventing assessment of visual or anatomical outcomes.
5.Non-adherence to treatment or follow-up, resulting in fewer than 3 documented visits post initiation.
6.History of systemic conditions severely affecting functional status or vision-related quality of life assessment (e.g., stroke, severe neurological disorders). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in best-corrected visual acuity (BCVA) measured in ETDRS letters, used to determine cost-effectiveness of anti-VEGF therapy versus comparators. |
Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, and 52 weeks (12 months). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in best-corrected visual acuity (BCVA) in ETDRS letters
Change in central macular thickness (CMT) on spectral-domain OCT
Indirect costs including lost workdays, travel, and caregiver burden
Change in vision-related quality of life using validated questionnaire (e.g., NEI VFQ-25 or EQ-5D) |
Baseline
3 months
6 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background:
Diabetic Macular Edema (DME) is a major cause of vision loss among individuals
with diabetes. Anti-VEGF therapy has revolutionized DME management by
significantly improving visual outcomes. However, the high cost of anti-VEGF
agents raises concerns about their affordability and cost-effectiveness,
particularly in resource-constrained public healthcare systems such as in
India.
Purpose:
This study aims to evaluate the cost-effectiveness of anti-VEGF therapy
compared to alternative treatments (e.g., corticosteroids and laser therapy) in
patients with DME, treated at a government-funded tertiary eye care center (Dr.
R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi).
Objectives:
- Primary Objective: To determine the incremental cost-effectiveness
ratio (ICER) of anti-VEGF therapy in comparison to laser and
corticosteroid treatments.
- Secondary Objectives: To assess clinical outcomes (change in BCVA and
CMT), estimate direct and indirect costs, and evaluate the economic burden
of DME from the patient and health system perspective.
Methods:
A retrospective cohort study will be conducted, reviewing medical records of
DME patients treated between January 2018 and March 2025. Data on visual
acuity, OCT findings, number of injections, and treatment costs will be
collected. ICER will be calculated using changes in ETDRS letters and cost
data. Quality of life and indirect costs will be assessed via a validated
questionnaire.
Sample Size:
Based on an expected moderate effect size in cost-effectiveness between
treatment groups and accounting for subgroup analysis, approximately 160 patients will be included.
Data
Analysis:
Cost-effectiveness will be expressed as ICER per ETDRS letter gained.
Descriptive statistics, comparative tests, and sensitivity analyses will be
conducted to test robustness of results.
Expected
Outcome:
The study is expected to provide data on whether anti-VEGF therapy offers good
value for money in the management of DME, thereby informing clinical and policy
decisions for optimizing eye care resources in India.
|