Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.NCT01707745
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
A study testing Intravitreal Bevacizumab in people with Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II., run by Sivakami A Pai at 1 site in United Arab Emirates.
Trial summary
Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP). Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II. Read more about this study
- Who is it for?
- Ages 32 to 42 weeks
- Conditions the study is for
- Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
- What is being tested?
- Intravitreal Bevacizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Refusal to give consent Critically ill neonates.
- -
Trial locations and contacts
1 site in 1 country.
Sivakami A Pai, MS, DNB, Phd contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Hospital
Dubai, UAE
Sivakami A Pai, MS, DNB, Phd, 00971504148256
Moza A Dekhain, MRCOpthal, FRCS, 009712195000 ext. 6272, maDekhain@dha.gov.ae
About this study
Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).
Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.
- Being tested
- Intravitreal Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal BevacizumabProcedure or surgery
Also called Intravitreal Avastin
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Other | Bevacizumab(Avastin) 0.75mg in 0.03 ml Receives: Procedure: Intravitreal Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression Of ROP
Measured: Minimum 6 months follow up after intravitreal Avastin
Secondary outcomes (1)
Recurrence of ROP
Measured: minimum 6 months of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sivakami A Pai
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Sivakami A Pai, Dubai Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707745
- Sponsor's protocol ID
- Avastin for threshold ROP.
- Status last verified
- Oct 2012
- First submitted
- 22 Sep 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
- ClinicalTrials.gov ID
- NCT01707745
- Acronym / sponsor ID
- Avastin for threshold ROP.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sivakami A PaiOther government
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).
Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin | Other | Procedure: Intravitreal BevacizumabBevacizumab(Avastin) 0.75mg in 0.03 ml |
Who may qualify
- Ages
- 32 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Refusal to give consent Critically ill neonates.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal BevacizumabAlso: Intravitreal Avastin | Procedure or surgery | Avastin |
Primary outcome
Regression Of ROP
Time frame: Minimum 6 months follow up after intravitreal Avastin
1 secondary outcome
Recurrence of ROP
Time frame: minimum 6 months of follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivakami A Pai, MS, DNB, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Bevacizumab in people with Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II., run by Sivakami A Pai at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sivakami A Pai, MS, DNB, Phd (00971504148256), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression Of ROP (time frame: Minimum 6 months follow up after intravitreal Avastin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.