| CTRI Number |
CTRI/2024/09/073792 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two modalities of treatment in combination and sole in patients with Diabetic Retinopathy |
|
Scientific Title of Study
|
Comparison of effect of combination therapy with intravitreal injection of Ranibizumab and photocoagulation versus Pan Retinal Photocoagulation in Severe Non Proliferative Diabetic retinopathy and Proliferative Diabetic Retinopathy with or without Macular edema |
| 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 Narendran BS |
| Designation |
Senior Resident |
| Affiliation |
Sri Devaraj Urs Academy of higher education and research |
| Address |
No: 22, Department of Ophthalmology First Floor, R. L. Jalappa Hospital and Research Tamaka Kolar – 563101 Karnataka
Kolar
KARNATAKA
563101
India |
| Phone |
9686922767 |
| Fax |
|
| Email |
narendranbs29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Inchara N |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Academy of higher education and research |
| Address |
No: 22, Department of Ophthalmology First Floor, R. L. Jalappa Hospital and Research Tamaka Kolar – 563101 Karnataka
Kolar
KARNATAKA
563101
India |
| Phone |
9000198625 |
| Fax |
|
| Email |
dr.inchara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Inchara N |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Academy of higher education and research |
| Address |
No: 22, Department of Ophthalmology First Floor, R. L. Jalappa Hospital and Research Tamaka Kolar – 563101 Karnataka
Kolar
KARNATAKA
563101
India |
| Phone |
9000198625 |
| Fax |
|
| Email |
dr.inchara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of higher education and research
No: 22, Department of Ophthalmology First Floor, R. L. Jalappa Hospital and Research Tamaka Kolar – 563101 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of higher education and research |
| Address |
Kolar Karnataka India 563101 |
| Type of Sponsor |
Private 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 NARENDRAN BS |
Sri Devaraj Urs Academy of higher education |
No:22 Department of Ophthalmology First Floor
Tamaka 563101
Kolar
KARNATAKA |
9686922767
narendranbs29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS MEDICAL COLLEGE |
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 |
Pan Retinal Photocoagulation |
Three sittings one week apart under Topical Anesthesia |
| Intervention |
Ranibizumab |
0.5mg (0.05 mL) Intravitreal
Monthly loading dose for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with Type-1 and Type-2 diabetes mellitus between 18 years to 65 years of age of both genders
2. Patients with severe NPDR or proliferative DR in both eyes with or without clinically significant macular edema (CSME) established by optical coherence tomography of Central Macular Thickness greater than 300 microns were included in the study
3. Visual impairment due to Diabetic Macular Edema in at least one eye
4. HbA1c Less than 10.0
5. High risk Proliferative Diabetic Retinopathy |
|
| ExclusionCriteria |
| Details |
1. History of prior laser treatment or vitrectomy in the study eye
2. Major surgery within the prior 6 months or planned within the next 28 days
3. Uncontrolled hypertension
4. Those patients with mature cataract or media opacities due to poor quality Optical Coherence Tomography images were all excluded from the study
5. Previous use of intravitreal corticosteroid application in phakic study eyes or chronic treatment with topical ocular or systemic corticosteroids
6. Those with previous treatment with anti angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.,) within three months of the day 0 (first day of treatment) visit.
7. Those with Proliferative Diabetic Retinopathy (PDR) in the study eye, iris neovascularization, vitreous hemorrhage, traction retinal detachment, or pre retinal fibrosis involving the macula in the study eye
8. Uncontrolled glaucoma and ocular trauma
9. Any condition that could affect follow up or documentation (including pre retinal or vitreous hemorrhage)
10. Changes in the vitreous-retinal interface (epiretinal membrane, macular hole and vitreoretinal traction syndrome)
11. Prior Thromboembolic events including myocardial infarction, stroke and deep vein thrombosis
12. Chronic Renal Failure
13.Decrease in vision due to other causes, vitreous hemorrhage, and concomitant conditions in the study eye or other ocular disorders that may confound interpretation of study results.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of ranibizumab on Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMT) every monthly in both groups |
month 3 to 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regression of Neovascularization: total Neovascularization Disc + Neovascularization Elsewhere (NVD+ NVE) |
Month 1 to 12 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="2"
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
|
This prospective interventional study will be conducted on 25 patients in each group fulfilling the inclusion and exclusion criteria in the department of ophthalmology R L Jalappa Hospital and Research , Kolar after obtaining Ethical clearance from Institutional ethical committee of Sri Devaraj Urs Academy of Higher Education and Research and written informed consent from the participants. The primary outcome of this study to measure Best Corrected Visual Acuity ( BCVA) and Central Macular Thickness ( CMT) every monthly in both groups to evaluate the effects of ranibizumab. The Secondary Outcome is regression of Neovascularization from base line to month 12. It will be recorded in both groups at 3. 6, 9, and 12 months follow up
|