This is a study to compare two chemotherapy regimens (Standard dose CEV vs High dose CEV) in retinoblastoma to find out, if higher dose regimen saves vision and eyeball better as compared to the standard dose regimen.

StandArd VEC vs high dose VEC with local THErapy for VIsion and globe Salvage in advanced IntraOcular retiNoblastoma (group D): A comparative RCT (SAVE-THE-VISION) study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064078

Enrollment

Registered

2024-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C692- Malignant neoplasm of retina

Interventions

Intervention1: High dose CEV: Vincristine (iv push) 0.025 mg/kg Max dose – 2 mg Carboplatin(infusion) 28 mg/kg/day Etoposide(infusion) 12 mg/kg/day Total 6 such cycles over 6 months Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1. All cases of newly diagnosed Unilateral Group D Intraocular Retinoblastoma 2. All cases of newly diagnosed bilateral Intraocular Retinoblastoma with at least one eye with Group D Intraocular Retinoblastoma 3. Age

Exclusion criteria

Exclusion criteria: 1. Any eye with extraocular retinoblastoma 2. Received any prior anti-neoplastic or local ophthalmic therapy 3. Relapsed cases

Design outcomes

Primary

Measure	Time frame
To compare the globe salvage rate in both the groups Timepoint: 6 months since last cycle of chemotherapy	—

Secondary

Measure	Time frame
To compare toxicity profile between both the groupsTimepoint: After each cycle;To compare vision salvage in both the groupsTimepoint: 6 months after last cycle; 3.To compare the median number of cycles of intravitreal chemotherapy required after completion of systemic chemotherapy for control of vitreous seeds in both the arms Timepoint: 6 months after last cycle;To incorporate the use of RB-RECIST for response assessment Timepoint: After every 2 cycle;To compare the median no of cycles required to achieve complete response Timepoint: 6 months after last cycle;To compare overall globe salvage after using IAC in both the groups Timepoint: 6 months after last cycle;To compare the number of patients requiring dose reductions or delay in chemotherapy due to severe toxicity in either arm.Timepoint: 6 months after last cycle	—

Measure

Time frame

To compare toxicity profile between both the groupsTimepoint: After each cycle;To compare vision salvage in both the groupsTimepoint: 6 months after last cycle; 3.To compare the median number of cycles of intravitreal chemotherapy required after completion of systemic chemotherapy for control of vitreous seeds in both the arms Timepoint: 6 months after last cycle;To incorporate the use of RB-RECIST for response assessment Timepoint: After every 2 cycle;To compare the median no of cycles required to achieve complete response Timepoint: 6 months after last cycle;To compare overall globe salvage after using IAC in both the groups Timepoint: 6 months after last cycle;To compare the number of patients requiring dose reductions or delay in chemotherapy due to severe toxicity in either arm.Timepoint: 6 months after last cycle

—

Countries

India

Contacts

Public ContactDebabrata Mohapatra

All India Institute of Medical Sciences

drrachnaseth1967@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026