| CTRI Number |
CTRI/2020/11/029120 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of Acanthamoeba keratitis with adjuvant oral Miltefosine. |
|
Scientific Title of Study
|
To assess the outcome of Acanthamoeba keratitis on combination of topical Biguanides and oral Miltefosine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Room No: 123, Clinical Research,
1st floor, GPR Building,
Kallam Anji Reddy Campus,
L V Prasad Marg, Banjara Hills,
Hyderabad 500 034.
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Room No: 123, Clinical Research,
1st floor, GPR Building,
Kallam Anji Reddy Campus,
L V Prasad Marg, Banjara Hills,
Hyderabad 500 034.
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Room No: 123, Clinical Research,
1st floor, GPR Building,
Kallam Anji Reddy Campus,
L V Prasad Marg, Banjara Hills,
Hyderabad 500 034.
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Profunda Inc. and Hyderabad Eye Research Foundation |
| Profunda Pharma and Hyderabad Eye Research Foundation, L V Prasad Eye Institute |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Instituta |
| Address |
L V Prasad Eye Institute,
Room No 123, Clinical Reasearch, GPR Building,
Kallam Anji Reddy Campus,
L V Prasad Marg, Banjara Hills,
Hyderabad 500 034
|
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
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 |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
L V Prasad Eye Institute,
Room No: 123, Clinical Research Departemnt,GPR Building,
Kallam Anji Reddy Campus,
L V Prasad Marg, Banjara Hills,
Hyderabad 500 034
Hyderabad
TELANGANA |
9618276424
04023548271
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B601||Acanthamebiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of tablet Miltefosine to the existing treatment |
Once the diagnosis of Acanthamoeba keratitis is confirmed microbiologically, all the patients will be advised the combination of biguanides (PHMB 0.02% with Chlorhexidine 0.02%) along with oral Miltefosine.
50mg thrice/twice a day for 1 to 2 months.
All patients will be given topical prednisoline acetate 3-4 times a day after 2-3 weeks of therapy after making sure of tectonic stability of cornea.All patients will be admitted for 1-2 days to look for tolerance and complte appropriate systematice examination will be done by physician.
Reduction in pain score, change in size of infiltrate,Miltefosine will be discontinued for 3 days and evaluated by physician. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age more than 18 years
2.Microbiologically proven Acanthamoeba keratitis
3.Patients willing to participate and follow up.
|
|
| ExclusionCriteria |
| Details |
1.Patients with age less than 18 years
2.Pregnant and lactating females
3.Patients who are likely to be pregnant are relative contraindicated.
4.Patient not willing to participate and follow up
5.Patients with known allergy to Miltefosine
6.Patients with epithelial or sub epithelial keratitis with only anterior stroma involvement with less than 4 mm.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BCVA, Healing time, Number of corneal ulcers responded on medical treatment |
0 week, 1 week, 2 week , 1 month, 3 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients needed glue or undergone therapeutic Penetrating keratoplasty (TPK) for worsening of infection. |
It will be observed as a pilot trial of 10 patients for 6 months and later continued for 2 years. we will perform analysis of these cases after 6 months
1 week, 1 month, 2 months and 4 months. |
|
|
Target Sample Size
|
Total Sample Size="109"
Sample Size from India="109"
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)
Modification(s)
|
20/11/2020 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acanthamoeba keratitis is a rare but potentially devastating amoebic infection of the cornea..Currently, the management of Acanthamoeba keratitis is diamidines and biguanides .With the use of these medications, resolution is achieved in 60-70% of the cases. But it needs long treatment duration and also associated severe ocular toxicity.Miltefosine, has been approved recently by the U.S. Food and Drug Administration for Acanthamoeba keratitis as an orhan drug category. In this prospective interventional study, we will evaluate its role as a first line systemic therapy in addition to the topical biguanides in combination.
NOTE: We will perform pilot study in 10 patient and do interim analysis and based on the results we will proceed or conclude the study.
We will include all the cases based on the clinical judgement and not exclude anterior stromal keratities or less than 4mm size.
|