| CTRI Number |
CTRI/2018/09/015622 [Registered on: 06/09/2018] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study Assessing the effect of Brolucizumab versus Aflibercept in Adult Patients
with Visual Damage related diabetes.
|
|
Scientific Title of Study
|
A Two-Year, Two-Arm, Randomized, Double-Masked,
Multicenter, Phase III Study Assessing the Efficacy and
Safety of Brolucizumab versus Aflibercept in Adult Patients
with Visual Impairment due to Diabetic Macular Edema |
| Trial Acronym |
KITE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRTH258B2302,Version no 01 dated 18 May 2018 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare PVT LTD |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare PVT LTD |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare PVT LTD |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
MAHARASHTRA
400051
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Belgium
Bulgaria
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
India
Latvia
Lebanon
Lithuania
Malaysia
Norway
Poland
Singapore
Slovakia
South Africa
Sweden
Switzerland
Taiwan
Turkey |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saravanan Veerapan |
Aravind Eye Hospital |
Room no 26 ,Retina clinic,Avinashi Road, Coimbatore - 641 014, Tamilnadu, India
Coimbatore
TAMIL NADU |
9790697555
saravananvr@gmail.com |
| Dr Naresh Babu K |
Aravind Eye Hospital Retina Vitreous services |
Room no 207,Retina clinic,# 1 Anna Nagar, Madurai- 625020 Tamilnadu India
Madurai
TAMIL NADU |
9443490920
cauveryeye@gmail.com |
| Dr Atul kumar |
Dr .Rajendraprasad Centre for ophthalmic sciences |
Dr.Rajendraprasad Centre for ophthalmic sciences, room no 272,AII India Insitute of Medical Sciences, Ansari Nagar, New Delhi 110 029
New Delhi
DELHI |
9810081996
atul56kumar@yahoo.com |
| Dr Vishali Gupta |
Post Graduate Insitute of Medical Edication and Research |
Room no 116,Advance Eye Centre, PGIMER, Sector 12 Chandigarh, India 160012
Chandigarh
CHANDIGARH |
9417565506
vishalisara@gmail.com |
| Dr Muna Bhende |
Sankara Nethralaya |
Deputy director, Bhagwan Mahavir Vitreo retina services,7th floor,MAHYPO BLOCK, 18/41,College Road
Chennai-600006
Chennai
TAMIL NADU |
44-28271616
drmuna@snmail.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Medical Research Foundation-Dr Naresh Babu |
Approved |
| Institutional Ethics committee Vision Research Foundation-Dr Gupta |
Approved |
| Institutional Human Ethics committee-Dr Sarvananan |
Approved |
| institutionsl Ethics Committee-Dr Atul Kumar |
Approved |
| L V Prasad Eye Institute Ethics Committee |
Approved |
| Vision Research Foundation Ethics-Muna Bhende |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, patients ≥18 years of age with either type 1
or 2 controlled diabetes mellitus and visual impairment due to diabetic
macular edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aflibercept 2 mg |
Administered intravenously, treatment consists of 5 loading dose at frequency of 4 week interval followed by injection at 8 week interval, duration 2 years. |
| Intervention |
Brolucizumab 6 mg |
Administered intravenously; treatment consist of 5 loading dose at 6 weekly interval followed by treatment ranging from frequency of 8 to 12 weekly interval; treatment duration is 2 years,
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients must give written informed consent before any study related
assessments are performed
2. Patients ≥18 years of age at baseline
3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at
screening
4. Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable
during the course of the study
Study Eye
5. Visual impairment due to DME with:BCVA score between 78 and 23 letters, inclusive, using Early
Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4 meters (approximate Snellen
equivalent of 20/32 to 20/320), at screening and baseline
ï‚· DME involving the center of the macula, with central subfield retinal
thickness (measured from RPE to ILM inclusively) of ≥340 μm on SD-OCT at screening
If both eyes are eligible, the eye with the worse visual acuity will be
selected for study eye. However, the investigator may select the eye
with better visual acuity, based on medical reasons or local ethical
requirements. |
|
| ExclusionCriteria |
| Details |
Previous treatment with any anti-VEGF drugs or investigational drugs
in the study eye
2. Active proliferative diabetic retinopathy in the study eye as per the
investigator
3. Concomitant conditions or ocular disorders in the study eye at
screening or baseline which could, in the opinion of the investigator,
prevent response to study treatment or may confound interpretation of
study results, compromise visual acuity or require medical or surgical
intervention during the first 12-month study period (e.g., cataract,
vitreous hemorrhage, retinal vascular occlusion, retinal detachment,
macular hole, or choroidal neovascularization of any cause)
4. Any active intraocular or periocular infection or active intraocular
inflammation (e.g., infectious conjunctivitis, keratitis, scleritis,
endophthalmitis, infectious blepharitis, uveitis) in study eye at
screening or baseline
5. Structural damage of the fovea in the study eye at screening likely to
preclude improvement in visual acuity following the resolution of
macular edema, including atrophy of the retinal pigment epithelium,
subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or
organized hard exudate plaques
6. Uncontrolled glaucoma in the study eye defined as intraocular pressure
(IOP) > 25 mmHg on medication or according to investigator’s
judgment, at screening or baseline
7. Neovascularization of the iris in the study eye at screening or baseline
8. Evidence of vitreomacular traction in the study eye at screening or
baseline which, in the opinion of the investigator, affect visual acuity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate that brolucizumab is non-inferior to aflibercept with respect
to the visual outcome |
after the first year of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study: Brolucizumab (RTH258) is non-inferior to aflibercept (Eylea) wrt visual outcome in last 3 months of first year.Potential to extend treatment intervals for RTH258 patients during the 2nd year of treatment.Functional & anatomical outcome with RTH258 relative to Eylea.Effect of RTH258 relative to Eylea on Diabetic Retinopathy status.Safety of RTH258 relative to Eylea.Effect of RTH258 relative to Eylea on patient reported outcomes (VFQ-25) |
End of the trial |
|
|
Target Sample Size
|
Total Sample Size="356"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "299"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2018 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
29/07/2018 |
| Date of Study Completion (Global) |
08/06/2021 |
|
Estimated Duration of Trial
|
Years="3"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The key design elements of this protocol will be posted in a publicly accessible database such as clinicaltrials.gov. In addition, upon study completion and finalization of the study report the results of this trial will be either submitted for publication and/or posted in a publicly accessible database of clinical trial results. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the safety and efficacy of Brolucizumab in treatment of patients withy visual impairment due to diabetic macular edema.
FPFV for India-1st Sep 2018 Recruitment Target for India-40 patients.
|