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CTRI Number  CTRI/2022/10/046696 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of treatment results of the cancer of the eye following different treatment modalities. 
Scientific Title of Study   Indocyanine green enhanced transpupillary thermotherapy Vs Transpupillary thermotherapy for treatment of thicker tumors in Retinoblastoma- A Randomised Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ipsita Barman 
Designation  Junior Resident 
Affiliation  Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi  
Address  Department of Ophthalmology, Ward 4A, 4th floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  8794032557  
Fax    
Email  ipsita95barman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachna Meel 
Designation  Additional Professor 
Affiliation  Dr Rajendra Prasad Centre for Ophthalmic Sciences 
Address  Room S7, 1st Floor, Unit 5, Department of Ophthalmology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, South Delhi

New Delhi
DELHI
110029
India 
Phone  9999768912  
Fax    
Email  dr.rachnameel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ipsita Barman 
Designation  Junior Resident 
Affiliation  Dr Rajendra Prasad Centre for Ophthalmic Sciences 
Address  Department of Ophthalmology, Ward 4A, 4th floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  8794032557  
Fax    
Email  ipsita95barman@gmail.com  
 
Source of Monetary or Material Support  
DR RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES, AIIMS, NEW DELHI, ANSARINAGAR, 110029 
 
Primary Sponsor  
Name  DR RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES 
Address  ANSARI NAGAR, AIIMS, NEW DELHI 
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 
Ipsita Barman  Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi  Room No.143, 1st floor, Ocular Oncology clinic, Department of Ophthalmology, R.P. Centre, AIIMS, New Delhi
New Delhi
DELHI 		 8794032557

ipsita95barman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C692||Malignant neoplasm of retina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ICG Enhanced Transpupillary Thermotherapy  For ICG Enhanced Transpupillary Thermotherapy, the dye (0.6 mg/kg) will be delivered intravenously after sensitivity testing and TTT will be commencing after 30 seconds. 
Intervention  Transpupillary Thermotherapy  Transpupillary Thermotherapy will be delivered using Laser Indirect Ophthalmoscope with 1.2 mm spot size using 810nm infrared laser (IRIDEX) using 20D lens. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1.TUMOR HEIGHT >6MM 2.TUMORS INVOLVING FOVEA 3.ANY MEDIA HAZE PRECLUDING THE VISIBILITY OF TUMOR LIKE VITREOUS HAEMORRHAGE/ VITREOUS SEEDS 4.LARGELY CALCIFIED TUMORS 5.NOT WILLING TO GIVE ONSENT 
 
ExclusionCriteria 
Details  1.TUMOR HEIGHT >6MM 2.TUMORS INVOLVING FOVEA 3.ANY MEDIA HAZE PRECLUDING THE VISIBILITY OF TUMOR LIKE VITREOUS HAEMORRHAGE/ VITREOUS SEEDS 4.LARGELY CALCIFIED TUMORS 5.NOT WILLING TO GIVE ONSENT 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate if ICG enhanced TTT achieves greater reduction in Tumor height as compared to TTT alone in thick Retinoblastoma.  Outcome will be assessed at baseline, 3weeks, 6weeks, 9weeks,12weeks under EUA OR till tumor height of less than 2mm, whichever is achieved earlier.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the complication rate between 2 groups.  Outcome will be assessed at baseline, 3weeks, 6weeks, 9weeks,12weeks under EUA OR till tumor height of less than 2mm, whichever is achieved earlier.  
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   27/10/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-12-2024 and end date provided 20-12-2046?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Focal treatment of Retinoblastoma include TTT, Cryotherapy, Brachytherapy & EBRT. These can be used as primary treatment for small tumors or in conjunction with chemotherapy for larger tumours (i.e.chemoreduction)

TTT is a sub-photocoagulation heat treatment using infrared diode (810 nm) laser directed at each tumor. TTT delivers heat at a lower temperature than that of classic photocoagulation, thereby producing hyperthermia without a photocoagulative effect. With the addition of ICG enhancement, there are two mechanisms at play: the thermal impact  & a photodynamic effect. Hyperthermia is directly cytotoxic & induces apoptosis while also inhibiting angiogenesis.In addition,the photodynamic effect generates reactive oxygen ,which induces irreversible damage to  neoplastic cells & their vasculature. The resulting so called photothermia produces synergistic tumoricidal effect ,which doubles the tissue destruction. The higher the concentration of ICG,the lower the fluence threshold of TTT.ICG is a green dye that binds tightly to plasma proteins and remains confined to the vascular system. It has a peak absorption spectrum at 800 nm.

Indocyanine green (ICG) is primarily used to examine the blood flow in choroid. ICG enhanced TTT has been used to treat Choroidal metastasis, melanoma and hemangioma. ICG is non toxic and safe in children. There are few studies in literature reporting the use of ICG enhanced TTT for treatment in Retinoblastoma.

 
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