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TO COMPARE TWO MODES OF TREATMENT IN A DISEASE AFFECTING THE INNER LAYERS OF THE EYE (RETINA) IN PREMATURE BABIES (RETINOPATHY OF PREMATURITY ONE EYE-LASER TREATMENT (LIGHT RADIATION) OTHER EYE-LASER AND INJECTION (OF A COMPOUND WHICH PREVENTS ABNORMAL NEW VESSEL FORMATION

TO COMPARE THE OUTCOMES OF LASER VS COMBINED LASER AND RANIBIZUMAB IN THRESHOLD RETINOPATHY OF PREMATURITY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021635
Enrollment
30
Registered
2019-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: COMBINED LASER AND RANIBIZUMAB TREATMENT IN THRESHOLD RETINOPATHY OF PREMATURITY: RANIBIZUMAB INJECTION WILL BE GIVEN INTRA VITREALLY IN ONE EYE TO THE INFANTS WITH B/L SYMMETRICAL THR

Sponsors

Dr Parijat chandra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.PRETERM BABIES WITH GA 2.B/L SYMMETRICAL THRESHOLD ROP - ZONE 1 OR 2 STAGE 3 ROP WITH PLUS DISEASE -EXTENT >5 CONTIGUOUS CLOCK HOURS OR >8 NON- CONTIGUOUS CLOCK HOURS -PLUS DISEASE 3.NO PREVIOUS TREATMENT FOR ROP

Exclusion criteria

Exclusion criteria: 1. PRE-THRESHOLD ROP 2. ADVANCED ROP STAGE 4/5 3. PREVIOUS LASER /ANTI-VEGF TREATMENT 4. OTHER OCULAR ABNORMALITY 5. BABIES WHOSE PARENTS ARE UNWILLING TO GIVE CONSENT FOR SURGERY

Design outcomes

Primary

MeasureTime frame
To compare outcomes of laser vs combined laser & ranibizumab in regression of threshold ROP.Timepoint: 12 WEEKS—

Secondary

MeasureTime frame
To compare the outcomes of laser vs combined laser & ranibizumab in management of threshold ROP in terms of recurrence of ROP with need for additional treatmentTimepoint: 12 WEEKS—

Countries

India

Contacts

Public ContactDR SHILPA VISWANATH

Dr R P C for ophthalmic sciences, AIIMS New delhi

parijatchandra@gmail.com01126593019

Outcome results

None listed

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