| CTRI Number |
CTRI/2018/05/013869 [Registered on: 14/05/2018] Trial Registered Prospectively |
| Last Modified On: |
05/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Eye drops to treat swelling related to eye inflammation |
|
Scientific Title of Study
|
Macular Edema Nepafenac vs. Difluprednate (MEND) Uveitis Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0 dated 20 Mar 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S R Rathinam |
| Designation |
Head of Uveitis Service |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Uvea Clinic
Room no. 250
2nd Floor, OPD Block
No.1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356223 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S R Rathinam |
| Designation |
Head of Uveitis Service |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Uvea Clinic
Room no. 250
2nd Floor, OPD Block
No.1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356223 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr S R Rathinam |
| Designation |
Head of Uveitis Service |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Uvea Clinic
Room no. 250
2nd Floor, OPD Block
No.1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356223 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
|
Source of Monetary or Material Support
|
| Proctor Foundation University of California, San Francisco, United States 94143 |
|
|
Primary Sponsor
|
| Name |
Proctor Foundation |
| Address |
Proctor Foundation University of California, San Francisco, United States 94143 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Bala Murugan |
Aravind Eye Hospital |
Uveitis services,
1st Floor,
OPD Room No. 50
Thavalakuppam,
Pondicherry-605 007
Pondicherry
PONDICHERRY |
914132619100
914132618848
drbalamuruganms@gmail.com |
| Dr VK Anuradha |
Aravind Eye Hospital |
Uvea Clinic
OPD Room no: 24,
Basement Floor,
Avinashi Road, Coimbatore - 641014
Coimbatore
TAMIL NADU |
914224360400
anuradhadr@aravind.org |
| Dr S R Rathinam |
Aravind Eye Hospital and PG Institute of Ophthalmology |
Uvea Clinic
Room no. 250
2nd Floor, OPD Block
No.1 Anna Nagar, Madurai, 625020, TamilNadu
Madurai
TAMIL NADU |
914524356223
914522530984
rathinam@aravind.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diluprednate 0.05% |
Diluprednate 0.05% topical corticosteroid eye drop 4x/day until Week 4 visit. If edema resolves, decrease to 1x/day until Week 6 visit, then stop. If not resolved at Week 4, continue 4x/day until Week 6 visit, then decrease to 1x/day until Week 8 visit, then stop. If edema not resolved by Week 6 or reoccurs at/after Week 6, treat per best medical judgement. |
| Intervention |
Diluprednate 0.05% eye drop and nepafenac 0.1% eye drop |
Combination treatment - Diluprednate 0.05% eye drop plus nepafenac 0.1% eye drop. Difluprednate eye drop 4x/day and nepafenac 3x/day until Week 4 visit. If edema resolves, decrease difluprednate to 1x/day and continue nepafenac 3x/day until Week 6 visit, then stop. If not resolved at Week 4, continue difluprednate 4x/day and nepafenac 3x/day until Week 6 visit, then decrease difluprednate to 1x/day and continue nepafenac 3x/day until Week 8 visit, then stop. If edema not resolved by Week 6 or reoccurs at/after Week 6, treat per best medical judgement. |
| Comparator Agent |
Prednisolone acetate 1% eye drop and nepafenac 0.1% eye drop |
Combination treatment - prednisolone acetate 1% eye drop plus nepafenac 0.1% eye drop. Prednisolone acetate eye drop 4x/day and nepafenac 3x/day until Week 4 visit. If edema resolves, decrease prednisolone acetate to 1x/day and continue nepafenac 3x/day until Week 6 visit, then stop. If not resolved at Week 4, continue prednisolone acetate 4x/day and nepafenac 3x/day until Week 6 visit, then decrease prednisolone acetate to 1x/day and continue nepafenac 3x/day until Week 8 visit, then stop. If edema not resolved by Week 6 or reoccurs at/after Week 6, treat per best medical judgement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Key Inclusion criteria:
1. ≥18 years of age
2. Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious)
3. Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature
4. If on oral corticosteroids, a stable dose of <10 mg prednisone/day for >4 weeks
5. If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for >4 weeks
6. If using prednisolone acetate 1% drops, stable regimen of ≤2 drops per day for >4 weeks
7. If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for ≥4 weeks with no anticipated changes to treatment during the trial
Eye-level Inclusion Criteria:
1. ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness (>320 µm by Heidelberg spectral-domain OCT)
2. Baseline intraocular pressure >5 mmHg and <21 mmHg
3. Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography
4. Best-corrected visual acuity of 5/200 or better
|
|
| ExclusionCriteria |
| Details |
Key Exclusion Criteria:
1. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline
2. Known allergy or hypersensitivity to any component of the study drugs
3. History of central serous chorioretinopathy in either eye
4. Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years
5. Presence of an epiretinal membrane—noted clinically or by OCT—in the study eye, thought to be significant enough to preclude improvement of ME
6. Previous pars plana vitrectomy
7. History of severe glaucoma (C/D ratio > 0.9 or any notching of optic nerve to rim)
8. Prior use of difluprednate or nepafenac in the past 4 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Central Subfield Thickness on OCT |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients achieving resolution, improvement, and recurrence of Macular edema by the Week 4 visit and by the Week 24 visit
2. BCVA at week 4
3. Quality of life assessment
4. Occurrence of Ocular hypertension and Cataract |
4 - 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2018 |
| 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="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study demonstrating that topical treatments are effective and safe would greatly impact practice patterns and treatment of macular edema secondary to uveitis. |