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CTRI Number  CTRI/2022/04/042226 [Registered on: 27/04/2022] Trial Registered Prospectively
Last Modified On: 04/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Role of giving peribulbar eye injection of amphotericin b for eye component of disease entity called invasive rhino-orbital mucor-mycosis as an early treatmnet 
Scientific Title of Study   Efficacy of using peribulbar injection of amphotericin b for invasive rhino-orbital mucor-mycosis – A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankur Singh 
Designation  Assistant professor  
Affiliation  The University College of Medical Sciences and GTB hospital  
Address  Department of ophthalmology University College of Medical Sciences and GTB hospital Dilshad Garden DELHI

East
DELHI
110095
India 
Phone  9878799215  
Fax    
Email  drankursingh1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankur Singh 
Designation  Assistant professor  
Affiliation  The University College of Medical Sciences and GTB hospital  
Address  Department of ophthalmology University College of Medical Sciences and GTB hospital Dilshad Garden DELHI

East
DELHI
110095
India 
Phone  9878799215  
Fax    
Email  drankursingh1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankur Singh 
Designation  Assistant professor  
Affiliation  The University College of Medical Sciences and GTB hospital  
Address  Department of ophthalmology University College of Medical Sciences and GTB hospital Dilshad Garden Delhi

East
DELHI
110095
India 
Phone  9878799215  
Fax    
Email  drankursingh1@gmail.com  
 
Source of Monetary or Material Support  
Guru Teg Bahadur Hospital 
 
Primary Sponsor  
Name  Guru Teg Bahadur Hospital 
Address  Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi 110095 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR A Singh  Guru Teg Bahadur Hospital  Departmnet of opthalmology; Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi 110095
East
DELHI 		 8860626736

drankursingh1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Guru Teg Bahadur Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H050||Acute inflammation of orbit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Peribulbar injection of amphotericin b  The patients having Rhino-orbital Mucormycosis along with standard of care patient shall receive extraconal inta-orbital local injections of Amphotericin B at the site of involvement.The maximum number extraconal local injections to be given shall be 9 (3 sets) with at least 3 days of a gap after every 3 injections. Patient would be evaluated for improvement or worsening based on proforma after 4 weeks of recruitment Patient shall also be evaluated based on proforma attached during the course of local injections as well as for 3 days post local injections. In case of clinico-radiological worsening, patient would be put to the rescue therapy of intraconal/retrobulbar Amphotericin B injections (standard of care) along with other standard of care interventions. 
Comparator Agent  Single arm study   NA 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Type A - Sub-clinical Rhino-orbital Mucormycosis cases - All cases being admitted at Guru Teg Bahadur Hospital, New Delhi have symptoms of Rhino-Mucormycosis with bony erosion of the (wall/walls) of orbit with orbital fat stranding or others, suggestive of breach of the orbital cavity on contrast-enhanced Computerized tomography.
Symptoms of Rhino-Mucormycosis:
1 Nasal stuffiness
2 Foul smell
3 Epistaxis
4 Nasal discharge - mucoid, purulent, blood-tinged or black
5 Nasal mucosal erythema, inflammation, purple or blue discolouration, white ulcer, ischemia, or eschar
The cases fulfilling the above criteria shall undergo microbiological confirmation for Mucorales before being recruited into group A.
Type B - Early Rhino-orbital Mucormycosis cases- This study shall also include all cases being admitted at Guru Teg Bahadur Hospital, New Delhi having symptoms of early Rhino-orbital Mucormycosis.
Definition of early clinical cases: Patients having subtle ocular signs having disease limited to extraconal compartment as seen on imaging.
1 Eyelid, periocular edema
2 Mild ptosis
3 Mild Ocular motility restriction
4 Facial paresthesia, anesthesia (infraorbital)
The cases fulfilling the above criteria shall undergo microbiological confirmation for Mucorales before being recruited into group B.
Microbiological confirmation - All cases would be confirmed for Mucorales by microbiological direct microscopy of samples drawn from deep nasal swabs or endoscopic guided nasal swabs or nasal biopsy as a part of the standard of care
 
 
ExclusionCriteria 
Details  1. Rhino-orbital Mucor mycosis patients having intraconal orbital involvement as seen on imaging.
2. Rhino-orbital Mucor mycosis patients having extraconal orbital involvement with best-corrected visual acuity less than 6/6. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome parameters:
For group A: Improvement in radiological parameters and non-progression of disease into the intraconal compartment of orbit.
For group B: Resolution of disease: Complete improvement in presenting ocular signs in patients having disease limited to extraconal compartment as seen on imaging. 		 Outcome parameters to be assessed daily during intervention and at the end of 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   04/05/2022 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM: To determine the efficacy of using Peribulbar injection of Amphotericin B for Invasive Rhino-Orbital Mucor-mycosis.

Primary Objectives:

1. To determine the role of local peribulbar injections in checking the further spread of infection in subclinical or early clinical cases of invasive Rhino-Orbital Mucor-mycosis.

Setting: Department of Ophthalmology, University College of Medical Sciences and GTB Hospital, Delhi-110095
Study Type: Prospective interventional Cohort Study.
Sample Size: Intervention group shall be limited to 15 cases; as it is a pilot study

Methods: This study would be a prospective interventional cohort single-arm study which would include two types of cases:

Definition of cases:

Type A: Sub-clinical Rhino-orbital Mucormycosis cases: All cases being admitted at Guru Teg Bahadur Hospital, New Delhi having symptoms of Rhino-Mucormycosis with bony erosion of the (wall/walls) of orbit with orbital fat stranding or others, suggestive of breach of the orbital cavity on contrast-enhanced Computerized tomography.

Type B: Early Rhino-orbital Mucormycosis cases:  This study shall also include all cases being admitted at Guru Teg Bahadur Hospital, New Delhi having symptoms of early Rhino-orbital Mucormycosis.

The exclusion criteria:

1. Rhino-orbital Mucor mycosis patients having intraconal orbital involvement as seen on imaging.

2. Rhino-orbital Mucor mycosis patients having extraconal orbital involvement with best-corrected visual acuity less than 6/6.

Intervention:
Along with the standard of care patient shall receive extraconal/peribulbar inta-orbital local injections of Amphotericin B at the site of involvement.
The maximum number of extraconal/peribulbar local injections to be given shall be 9 (3 sets) with at least 3 days of a gap after every 3 injections.
The patients would be evaluated for improvement or worsening based on the proforma attached after 4 weeks of recruitment
The patients shall also be evaluated based on proforma attached during the course of local injections as well as for 3 days post local injections.
In case of clinico-radiological worsening, the patients would be put to the rescue therapy of intraconal/retrobulbar Amphotericin B injections (standard of care) along with other standard of care intervention .

Outcome parameters: -

For group A: Improvement in radiological parameters and non-progression of disease into the intraconal compartment of orbit.
For group B: Resolution of disease: Complete improvement in presenting ocular signs in patients having disease limited to extraconal compartment as seen on imaging.

Treatment Success: All recruited patients showing clinic-radiological improvement at the end of the 4 weeks from the first dose of peribulbar amphotericin B.

• Improvement in radiological parameters suggestive of regression of orbital disease in cases with no clinical ocular involvement.

• Complete resolution of presenting ocular signs in patients with disease limited to extraconal compartment as seen on imaging.

Treatment Failure: All recruited patients showing the following at the end of 4 weeks post first dose of peribulbar amphotericin B or at any follow-ups post recruitment.

• Clinic-radiological progression of disease into intraconal space requiring intraconal/retrobulbar injections of amphotericin B,

• Clinic-radiological worsening with involvement of intraconal space, orbital apex, optic nerve requiring exenteration.


Novelty/Innovation: As of today, there are no established guidelines or available literature for the treatment of subclinical or early orbital mucor-mycosis patients. Imaging like computerized tomography or magnetic resonance imaging of paranasal sinus and orbit can identify preclinical or subclinical disease. Early check of the infection by local therapy and combined Sino-nasal debridement may have a potential vision and functionality salvageable role. As well as prevent complications associated with retrobulbar injections( as part of the standard of care).

Previous studies/Literature: Invasive fungal rhino-orbital sinusitis (IFROS) is a highly morbid and rare disease. Available literature has demonstrated the role of functional endoscopic or conventional sinus surgery with biopsy and debridement of affected tissues when combined with intraconal injections or local amphotericin B irrigation, improves the survival as well as lowers the need for disfiguring exenteration. Limited literature and anecdotal case reports have demonstrated the role of intraconal/retrobulbar injections of amphotericin B in the management of established orbital mucor-mycosis. While few other case reports have demonstrated the role of local amphotericin B irrigation of both intraconal and/or extraconal/peribulbar spaces for local control of infection post debridement.


Extraconal/peribulbar - route as well as drug Amphotericin B is well documented in the treatment of Rhino-Orbital Mucor-mycosis in the existing literature.

 
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