| CTRI Number |
CTRI/2025/09/094346 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Anti-VEGF Injection Combined with Dorzolamide - Timolol Eye Drops in Patients with Diabetic Macular Swelling |
|
Scientific Title of Study
|
THE EFFECT OF COMBINATION THERAPY WITH INTRAVITREAL ANTI-
VEGF AND TOPICAL DORZOLAMIDE TIMOLOL EYE DROPS ON
DIABETIC MACULAR OEDEMA IN COMPARISON TO STANDALONE
INTRAVITREAL ANTI-VEGF |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neel Nathmal Kavediya |
| Designation |
MS Ophthalmology Post Graduate |
| Affiliation |
Madras Medical College RIO-GOH, Chennai |
| Address |
Tower A 206 SPR City Highliving Apartment , Perumbur Chennai 600011
Regional institute of ophthalmology and government ophthalmic hospital, Chennai Egmore 600008
Chennai
TAMIL NADU
600011
India |
| Phone |
7020351145 |
| Fax |
|
| Email |
kavediya.neel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr. M. Hemanandini |
| Designation |
M.S,D.O. |
| Affiliation |
Madras Medical College, Chennai |
| Address |
Regional Institute of ophthalmology and government ophthalmic hospital, Egmore
Old Number-84, New Number-20, Millers Road, Kilpauk Chennai 600010
Chennai
TAMIL NADU
600008
India |
| Phone |
6381914697 |
| Fax |
|
| Email |
drhema0608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neel Nathmal Kavediya |
| Designation |
MS Ophthalmology Post Graduate |
| Affiliation |
Madras Medical College RIO-GOH, Chennai |
| Address |
Tower A 206 SPR City Highliving Apartment , Perumbur Chennai 600011
Regional institute of ophthalmology and government ophthalmic hospital, Chennai Egmore 600008
Chennai
TAMIL NADU
600011
India |
| Phone |
7020351145 |
| Fax |
|
| Email |
kavediya.neel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Medical College and Rajiv Gandhi Government General hospital, Ophthalmology dept RIO-GOH, India , Tamil Nadu Egmore Chennai 600008 |
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
MADRAS MEDICAL COLLEGE OPHTHAL DEPARTMENT - REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL, Rukmani Lakshmipathi Rd, Pudupet, Komaleeswaranpet, Egmore, Chennai, Tamil Nadu 600008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Neel Nathmal Kavediya |
Madras Medical College and Hospitals, Chennai |
M.S. Ophthalmology department, RIO-GOH, sub-department of uvea and medical retina , 3rd Floor New Building
Chennai
TAMIL NADU |
07020351145
kavediya.neel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - Madras Medical College Chennai 600003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% artificial tears as placebo with injection avastin only |
dose : single drop, two times a day BD topically
total duration : 4 months
|
| Intervention |
dozolamide 2% timolol 0.5% eye drops combination along with avastin/anti vegf injection |
dose : single drop, two times a day BD topically
total duration : 4 months
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 40yrs
Patients with centre involving diabetic macular edema with central foveal thickness of more than 300 microns |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the anatomical and functional outcome with intravitreal bevacizumab(IVB) and topical timolol-dorzalamide versus intravitreal bevacizumab alone in terms of central foveal thickness |
Baseline - 1st Visit
After 4 weeks - 1st Follow Up
After 8 weeks - 2nd Follow Up
After 12 weeks - 3rd Follow Up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the variation in IOP of the patient |
Baseline - 1st Visit
After 4 weeks - 1st Follow Up
After 8 weeks - 2nd Follow Up
After 12 weeks - 3rd Follow Up |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 and Rationale: Diabetic Macular Edema (DME) is a leading cause of visual morbidity. Intravitreal anti-VEGF agents are the mainstay of treatment. Recent evidence suggests that aqueous suppressants like dorzolamide-timolol may prolong intravitreal drug action by reducing aqueous outflow and attenuate post injection rise in IOP, thereby potentially improving the efficacy. This study aims to evaluate whether adjuvant dorzolamide-timolol enhances the therapeutic effect of intravitreal bevacizumab in DME.
Study Design: Hospital based RCT, single centre and parallel group
Study Population:
Patients>40yrs with centre involving DME and Central Foveal Thickness >300microns Exclusion: Extrafoveal DME, Vitreous Haemorrage, tractional bands, glaucoma and any person on anti-glaucoma therapy, CAD,CKD, sulpha allergy
Intervention: GROUP-A (IVB+TD) : Monthly intravitreal Bevacizumab (IVB) injection + dorzolamide - timolol eye drops twice a daily GROUP-B (IVB only) : Monthly Intravitreal Bevacizumab (IVB) injection + articifical tear drops
Sample Size: 80 subjects (40 per arm), with 80% power and 5% alpha error
Outcome Measure: Primary: Change in CFT Secondary: Changes in BCVA and IOP variations |