A study to evaluate the response of injection melphalan along with intravenous chemotherapy in retinoblastoma patients

Evaluation of Vitreous Seed Regression using Intravitreal Melphalan in Combination with Intravenous Chemotherapy for Persistent / Partially Regressing Vitreous Seeds in Group C and D Retinoblastoma

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015860

Enrollment

Registered

2018-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: INJ MELPHALAN: Melphalan will be used in a dose of 20-30 mcg per injection depending on the distribution and extent of the seeds (20 mcg for focal seeds or fine dust like seeds, 30 mcg

Eligibility

Inclusion criteria

Inclusion criteria: A. For intravitreal chemotherapy with intravenous chemotherapy: i. Eyes with group C/ D Retinoblastoma with partially regressed/ persistent Vitreous seeds at the end of 3-4 cycles of intravenous chemotherapy ii. Eyes with group B retinoblastoma that have progressed to develop vitreous seeds B. For primary intravitreal chemotherapy i. Unilateral group D eye with poor visual prognosis, where parents have given consent for trial of primary intravitreal chemotherapy as globe salvage option

Exclusion criteria

Exclusion criteria: i. Retinal tumor progression requiring radiotherapy ii. Appearance of clinical features suggestive of high risk of metastasis like hyphaema/ anterior segment seeds/ raised IOP, neovascularization of iris iii. Development of vitreous hemorrhage and RD after starting intervention iv Inability to achieve a distance of 1 clock hour from vitreous seeds at the time of injection

Design outcomes

Primary

Measure	Time frame
To evaluate vitreous seed regression in group C and D retinoblastoma with persistent vitreous seeds after 3 cycles of intravenous chemotherapy using additional intravitreal chemotherapyTimepoint: after every 2 weeks of intravitreal injection	—

Secondary

Measure	Time frame
To evaluate : 1. Globe salvage with intravitreal chemotherapy and intravenous chemotherapy 2. Visual acuity outcome (where possible) in cases with globe salvage in non-macular tumors with complete vitreous seed regression 3.Retinal changes after intravitreal chemotherapy(where possible): FFA 4.Histopathological changes in eyes enucleated after failed intravitreal chemotherapy. 5.Effect on retinal tumor with primary intravitreal chemotherapy.Timepoint: after 2 weeks of intra vitreal therapy	—

Measure

Time frame

To evaluate : 1. Globe salvage with intravitreal chemotherapy and intravenous chemotherapy 2. Visual acuity outcome (where possible) in cases with globe salvage in non-macular tumors with complete vitreous seed regression 3.Retinal changes after intravitreal chemotherapy(where possible): FFA 4.Histopathological changes in eyes enucleated after failed intravitreal chemotherapy. 5.Effect on retinal tumor with primary intravitreal chemotherapy.Timepoint: after 2 weeks of intra vitreal therapy

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Countries

India

Contacts

Public ContactAparna M

DR RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES,AIIMS

drrachnameel@gmail.com9868846891

Outcome results

None listed

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