Clinical trial
Compassionate Use Pan-VEGF Blockade for the Treatment of ROP (Compassionate Use BLOCK-ROP) Trial
Name
CCI-09-00044
Description
The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for retinopathy of prematurity.
Trial arms
Treatment
Bevacizumab (Avastin)
Dosage of 0.75mg/0.03ml intravitreal injectable, one time only.
Other names:
Avastin
Size
-1
Eligibility criteria
Inclusion Criteria:
* Inborn babies at CHLA NICU
* Outborn babies transferred to CHLA NICU
* Zone 1 or 2 ROP
* Adequate/appropriate laser ablation
* Failed standard laser treatment (persistent Plus disease at a minimum of 1 week post-laser)
* Post-menstrual age greater than 30 weeks
Exclusion Criteria:
* Zone 3 ROP
* Inadequate initial laser treatment
* Most recent laser treatment less than 1 week
* Evidence of tractional retinal detachment (exudative retinal detachment may be included in study group)
* Post-menstrual age less than 30 weeks
* Health not allowing for full protocol participation (determined by neonatologist)
Protocol
{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}
Updated at
2023-11-24
1 organization
1 product
1 indication
Organization
Children's Hospital Los AngelesProduct
BevacizumabIndication
Retinopathy of Prematurity