| CTRI Number |
CTRI/2018/03/012383 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of branch retinal vein occlusion treatment with ultra wide-field imaging guided peripheral scatter laser in combination with ranibizumab ( anti-VEGF for macular edema in BRVO) vs ranibizumab only in treatment naive cases. |
|
Scientific Title of Study
|
prospective randomized interventional trial comparing branch retinal vein occlusion treatment with ultra wide field imaging guided peripheral laser in combination with ranibizumab vs ranibizumab only in treatment naive cases. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IESC/T-337/23.06.2015, RT-32/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi Goel |
| Designation |
Junior Resident (Ophthalmology) |
| Affiliation |
AIIMS |
| Address |
RPC, AIIMS, Ansari Nagar New Delhi-110029
South
DELHI
110029
India |
| Phone |
9810032869 |
| Fax |
|
| Email |
siddhigoel91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahesh Chandra |
| Designation |
Professor(Ophthalmology) |
| Affiliation |
AIIMS |
| Address |
RPC, AIIMS, Ansari Nagar New Delhi-110029
South
DELHI
110029
India |
| Phone |
9868289233 |
| Fax |
|
| Email |
maheshchandra04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhi Goel |
| Designation |
Junior Resident (Ophthalmology) |
| Affiliation |
AIIMS |
| Address |
RPC, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9810032869 |
| Fax |
|
| Email |
siddhigoel91@gmail.com |
|
|
Source of Monetary or Material Support
|
| RPC, AIIMS, Ansari Nagar New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
ansari nagar, new delhi 110029 |
| 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 |
| Dr Siddhi Goel |
RPC, AIIMS |
Ansari Nagar, New Delhi
South
DELHI |
9810032869
siddhigoel91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee for post graduate research,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
BRVO with macular edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ranibizumab and laser |
treatment of brvo with macular edema with ranibizumab and laser |
| Comparator Agent |
ranibizumab only |
treatment of brvo with macular edema with ranibizumab only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of BRVO with macular edema with evidence of capillary non perfusion
2. Macular edema involving center of fovea
3. BCVA at baseline- 3/60-6/18 by Snellen’s visual acuity
4. Mean central subfield thickness > 300 micrometer by OCT at baseline visit
5. Informed consent
6. Media clarity, pupillary dilatation and patient cooperation sufficient for fundus photography
|
|
| ExclusionCriteria |
| Details |
1. other ocular diseases like AMD eyes, diabetic retinopathy, disc pallor
2. recent CVA, MI or major ischemic event 3 months preceding baseline visit
3. known sensitivity to any anti-VEGF drugs and sodium fluorescein
4. previous macular or pan retinal photocoagulation
5.previous anti-VEGF treatment
6.no consent
7.patient not willing for follow up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BCVA ( snellens visual acuity and ETDRS) |
1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OCT
number of ranibizumab injections
contrast sensitivity |
1 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2015 |
| Date of Study Completion (India) |
30/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.
In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first 3 months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent 3 months. The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections The purpose of the study is to assess whether peripheral scatter laser has any role in decreasing the macular edema in BRVO patients in addition to anti-VEGF ( Ranibizumab ).
Ultrawidefield FA reveals correlation between non perfusion in the peripheral retina with macular edema and retinal neovascularisation. The study hypothesis is to determine if laser photocoagulation of the non perfused retina decreases macular edema and neovascularisation. |