| CTRI Number |
CTRI/2025/09/093952 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Eye Study: How Anti-VEGF Injections Affect Eye Nerves and Blood Flow, and Whether Brimonidine Drops Help |
|
Scientific Title of Study
|
To Analyse Acute Peripapillary Angiographic and Retinal Nerve Fibre Layer changes following intravitreal anti-VEGF injections: a case-control study with and without use of Brimonidine eye drops. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAVITHRA R V |
| Designation |
SECONDARY DNB TRAINEE |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
ROOM NO 24, RETINA DEPARTMENT, SANKARA EYE HOSPITAL , BANGLORE
VARTHUR MAIN ROAD , KUNDALAHALLI GATE ,BANGLORE - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9663949083 |
| Fax |
|
| Email |
dr.pavithra5080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MINIJA C K |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
ROOM NO 24, RETINA DEPARTMENT, SANKARA EYE HOSPITAL
VARTHUR MAIN ROAD , KUNDALAHALLI GATE ,BANGLORE - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9480587018 |
| Fax |
080-28542728 |
| Email |
minija_ck@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
PAVITHRA R V |
| Designation |
SECONDARY DNB TRAINEE |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
ROOM NO 24, RETINA DEPARTMENT, SANKARA EYE HOSPITAL, BANGLORE
VARTHUR MAIN ROAD , KUNDALAHALLI GATE ,BANGLORE - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9663949083 |
| Fax |
|
| Email |
dr.pavithra5080@gmail.com |
|
|
Source of Monetary or Material Support
|
| RETINA DEPARTMENT , SANKARA EYE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SANKARA EYE HOSPITAL |
| Address |
RETINA DEPARTMENT,ROOM NO 24,
SANKARA EYE HOSPITAL
VARTHUR MAIN ROAD, KUNDALAHALLI GATE, BANGLORE |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| PAVITHRA R V |
SANKARA EYE HOSPITAL |
ROOM NO 24, RETINA DEPARTMENT,VARTHUR MAIN ROAD, KUNDALAHALLI GATE , BANGLORE -560037
Bangalore
KARNATAKA |
09663949083
dr.pavithra5080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H353||Degeneration of macula and posterior pole, (3) ICD-10 Condition: H349||Unspecified retinal vascular occlusion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRIMONIDINE 0.15 PERCENT EYE DROP |
CASES WILL RECEIVE SINGLE DROP OF BRIMINIDINE 0.15 PERCENT EYE DROP 30 MINUTES BEFORE INJECTION |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)PATIENTS INDICATED FOR INTRAVITREAL ANTI-VEGF INJECTION (EG-DIABETIC MACULAR EDEMA, AGE-RELATED MACULAR DEGENERATION, RETINAL VEIN OCCLUSIONS)
2)BEST CORRECTED VISUAL ACUITY MORE THAN 6/60
3)AGE GREATER THAN 18 YEARS
4)CLEAR MEDIA
5)PHAKIC OR PSEUDOPHAKIC EYES
6)GOOD FIXATION ABILITY
7)INTRAOCULAR PRESSURE LESS THAN 21 MMHG BEFORE INJECTION
8)CONSENT TO PARTICIPATE IN THE STUDY |
|
| ExclusionCriteria |
| Details |
1)KNOWN ALLERGY TO BRIMONIDINE 0.15 PERCENT EYE DROP
2)USE OF ANY INTRAOCULAR PRESSURE LOWERING EYE DROPS WITHIN THE PAST 2 WEEKS.
3)HISTORY OF UVEITIS OR OCULAR INFLAMMATION
4)PREVIOUS VITRECTOMY OR GLAUCOMA SURGERY IN THE STUDY EYE
5)KNOWN CASE OF GLAUCOMA
6)MEDIA OPACITIES (DENSE CATARACT, CORNEAL OPACITY, VITREOUS HAEMORRHAGE)
7)POOR OCT, OCT-A IMAGE QUALITY
8)HIGH MYOPIA (MORE THAN -6.00 D SPHERICAL EQUIVALENT OR AXIAL LENTH MORE THAN 26.5MM)
9)CONCURRENT RETINAL PATHOLOGIES LIKE RETINAL DETACHMENT, MACULAR HOLE
10)APHAKIC EYES
11)PATIENTS UNDERGOING TREATMENT WITH AFLIBERCEPT 0.1ML |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGE IN PERIPAPILLARY RETINAL NERVE FIBRE LAYER THICKNESS AND PRIPAPILLARY VASCULAR PERFUSION DENSITY |
30 MINUTES BEFORE AND AFTER THE INTRAVITREAL ANTI-VEGF INJECTION. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGE IN INTRAOCULAR PRESSURE |
BEFORE AND 5 MINUTES AFTER INTRAVITREAL ANTIVEGF INJECTION |
| CORRELATION BETWEEN INTRAOCULAR PRESSURE AND PERIPAPILLARY RETINAL NERVE FIBRE LAYER AND VASCULAR CHANGES(VESSEL DENSITY, PERFUSION DENSITY) |
|
| SAFETY AND FEASIBILITY OF BRIMONIDINE USE |
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
02/09/2025 |
| 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="1"
Months="0"
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
|
TITLE: ANALYSIS OF ACUTE PERIPAPILLARY ANGIOGRAPHIC AND RETINAL NERVE FIBRE LAYER CHANGES FOLLOWING INTRAVITREAL ANTI-VEGF INJECTIONS: A CASE CONTROL STUDY WITH AND WITHOUT BRIMONIDINE EYE DROPS.OBJECTIVE: TO EVALUATE THE ACUTE EFFECTS OF INTRAVITREAL ANTI-VEGF INJECTIONS ON PERIPAPILLARY RETINAL NERVE FIBRE LAYER (RNFL) THICKNESS, AND MICROVASCULATURE(VESSEL AND PERFUSION DENSITY) USING OCT AND OCT-A. THIS STUDY ALSO AIMS TO ASSESS THE PROTECTIVE ROLE OF BRIMONIDINE 0.15 PERCENT PROPHYLAXIS AGAINST THESE CHANGES.
STUDY DESIGN: CASE-CONTROL STUDY (AUGUST 2025-JULY 2026) AT SANKARA EYE HOSPITAL, BENGALURU. - CASES: EYES PRE-TREATED WITH BRIMONIDINE 0.15 PERCENT EYE DROP , 30 MINUTES BEFORE ANTI-VEGF INJECTION -CONTROLS: EYES WITHOUT BRIMONIDINE.
SAMPLE SIZE: 220 EYES(110 PER GROUP), ACCOUNTING FOR EXCLUSIONS, POWERED TO DETECT A MEAN DIFFERENCE OF 2.3 IN RNFLTHICKNESS (STANDARD DEVIATION IS EQUAL TO 7, 90 PERCENT POWER, 95 PERCENT CONFIDENCE INTERVAL
METHODOLOGY: -BASELINE AND POST-INJECTION (WITHIN 60 MINUTES, PREFERABLY AT 30 MINUTES) MEASUREMENTS OF IOP(TONOPEN), RNFL THICKNESS(OCT), AND PERIPAPILLARY MICROVASCULATURE (OCT-A) -STATISTICAL ANALYSIS USING SPSS (PEARSON’S CORRELATION FOR IOP-RNFL AND IOP-VASCULAR CHANGES; P LESS THAN 0.05 SIGNIFICANT).
EXPECTED OUTCOMES: 1. REDUCED RNFL THINNING AND MICROVASCULATURE COMPROMISE IN BRIMONIDINE-TREATED EYES 2. LOWER IOP SPIKES IN THE BRIMONIDINE GROUP 3. POSITIVE CORRELATION BETWEEN IOP RISE AND RNFL AND PERFUSION LOSS IN CONTROLS
SIGNIFICANCE: POTENTIAL TO VALIDATE BRIMONIDINE’S NEURO-PROTECTIVE ROLE, OPTIMIZE SAFETY PROTOCOLS, AND GUIDE PROPHYLACTIC USE IN HIGH-RISK PATIENTS (GLAUCOMA SUSPECTS)
ETHICS: APPROVED BY INSTITUTIONAL SCIENTIFIC AND ETHICS COMMITTEES
KEYWORDS: ANTI-VEGF, BRIMONIDINE, RNFL, OCT, OCT-A, IOP SPIKES, PERIPAPILLARY MICROVASCULATURE |