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NCT02640664 · ClinicalTrials.gov registry record · Phase 3
Rainbow Extension Study
A Phase 3 study of Retinopathy of Prematurity (ROP), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT02640664: Completed Phase 3 study of Retinopathy of Prematurity (ROP), sponsored by Novartis Pharmaceuticals.
NCT02640664 is a Phase 3 study of Retinopathy of Prematurity (ROP) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 180 participants, below the 2,499-participant average among 3 other Retinopathy of Prematurity (ROP) trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02640664, a Phase 3 study of Retinopathy of Prematurity (ROP), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
Primary Outcome
The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seein
Conditions Studied
Interventions
- DRUG Ranibizumab
Study Locations (20)
Other
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Bruges
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Zagreb
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Koebenhavn Ø
- Novartis Investigative Site - Alexandria
- Novartis Investigative Site - Tallinn
California
- Novartis Investigative Site - Sacramento
Colorado
- Novartis Investigative Site - Aurora
Illinois
- Novartis Investigative Site - Chicago
Kentucky
- Novartis Investigative Site - Louisville
Maryland
- Novartis Investigative Site - Baltimore
Michigan
- Novartis Investigative Site - Ann Arbor
New York
- Novartis Investigative Site - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2016-06-16 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 3 |
What the finished NCT02640664 record still lists
NCT02640664 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 2,499-participant average among 3 other Retinopathy of Prematurity (ROP) trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Retinopathy of Prematurity (ROP) appearing as the primary indexed condition, and to 1 intervention - of which Ranibizumab is the first listed.
NCT02640664 names 20 study sites across 12 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02640664 about?
NCT02640664 is a clinical study titled "Rainbow Extension Study". The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
What is the current status of trial NCT02640664?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2016-06-16. Estimated completion is 2022-04-21.
What conditions does trial NCT02640664 study?
This clinical trial studies the following conditions: Retinopathy of Prematurity (ROP).
What interventions are being tested in trial NCT02640664?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT02640664?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02640664 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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