Age Related Macular DegenerationNCT01626339
Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter
A study testing Intravitreal Ranibizumab and Intravitreal bevacizumab in people with Age Related Macular Degeneration, run by University of Malaya at 1 site in Malaysia.
Trial summary
Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Intravitreal Ranibizumab and Intravitreal bevacizumab
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2012to Jun 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease
Who cannot join
- History of previous systemic or ocular Anti-VEGF therapy
- History of previous intravitreal injection with any drug
- Intraocular pressure ≥ 22
- Glaucoma
- History or presence of thromboembolic events
- Un-controlled blood pressure
- Blood donation during the previous 3 weeks
- Relevant media opacity of the lens
Trial locations and contacts
1 site in 1 country.
Visvaraja Subrayan, Prof contact
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
Mohammadreza Peyman, MD, 0060173387260, drmpeyman@yahoo.com
About this study
Official title: Effect of Intravitreal Anti-Vascular Endothelial Growth Factors on Retinal Vessels Diameter
Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE).
Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye
- Conditions
- Age Related Macular Degeneration
- Being tested
- Intravitreal Ranibizumab, Intravitreal bevacizumab
- Keywords
- Anti vascular endothelial growth factor, retinal vessels
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal RanibizumabDrug
Also called Lucentis
Intravitreal bevacizumabDrug
Also called Avastin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626339
- Sponsor's protocol ID
- PPUM/MDU/300/04/03
- Status last verified
- Jun 2012
- First submitted
- 20 Jun 2012
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Anti-Vascular Endothelial Growth Factors on Retinal Vessels Diameter
- ClinicalTrials.gov ID
- NCT01626339
- Acronym / sponsor ID
- PPUM/MDU/300/04/03
- Conditions
- Age Related Macular Degeneration
- Keywords
- Anti vascular endothelial growth factor, retinal vessels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (estimated)
- First posted
- 22 Jun 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.
Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE).
Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye
Study design
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease
Key exclusion criteria (8 listed)
- History of previous systemic or ocular Anti-VEGF therapy
- History of previous intravitreal injection with any drug
- Intraocular pressure ≥ 22
- Glaucoma
- History or presence of thromboembolic events
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 RanibizumabAlso: Lucentis | Drug | – |
| Intravitreal bevacizumabAlso: Avastin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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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.
Visvaraja Subrayan, Prof 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 Ranibizumab and Intravitreal bevacizumab in people with Age Related Macular Degeneration, run by University of Malaya at 1 site in Malaysia.
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 1 inclusion and 8 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 22 Jun 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 Malaysia. 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 Mohammadreza Peyman, MD (0060173387260 ext. 1, drmpeyman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Jun 2012.