Diabetic Macular EdemaVEGFNCT01196325
Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy
An observational study of Diabetic Macular Edema, run by University of Toronto at 1 site in Canada.
Trial summary
The study will investigate changes in the structure and function of blood vessels in the front and back of the eye following laser and anti-VEGF treatments for sight-threatening diabetic eye disease. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Aug 2014
- Phase
- Observational
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 2 diabetic patients with clinically sight-threatening Diabetic Macular Edema will be recruited from the Retina Clinics of Toronto Western Hospital.
Who may be able to join
- Age range of 35-75 yrs
- Type 2 diabetes apart from age-matched control group
- Visual acuity of 20/400 or better
- Confirmed diagnose of Clinical Significant Diabetic Macular Edema (applies for Diabetic Groups only)
- Previously untreated eye for retinal diseases and disorders
Who cannot join
- Distance refractive error > ± 6.00 DS \& / or ± 2.50 DC
- Intraocular pressure ≥ 22mm Hg
- Proliferative Diabetic Retinopathy
- Any other active eye disease and disorder
- Participants with history of cardiovascular events, stroke, thromboembolic events, transient ischemic attack, uncontrolled hypertension.
- Any active ocular infection;
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- History of glaucoma;
- Known allergy, hypersensitivity or contraindication to the study medication;
- Pregnancy, breast feeding, or women of childbearing potential who are not using a reliable method of contraception;
- Proteinuria and/or renal impairment;
- Surgery within the past 28 days.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Olena Puzyeyeva, MD, (416)603-5694, opuzyeye@uhnresearch.ca
Lee-Anne Khuu, MSc, (416)603-5694, lkhuu@uhnresearch.ca
About this study
Official title: Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy.
The study will investigate changes in the structure and function of blood vessels in the front and back of the eye following laser and anti-VEGF treatments for sight-threatening diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control subjects and diabetic patients who require conventional or contemporary treatment for pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment using state-of-the-art techniques to measure vision, the rate of blood flow and structure at the front and back of the eye and the effectiveness of blood flow delivery. Changes following treatment in these novel, non-invasive techniques will be quantified and described. We anticipate that conventional and new / developing treatments will lead to narrowing of the vessels and consequent reduction of blood flow at the back and front of the eye. There will be a strong relationship between structural changes of the eye and functional changes of blood vessels at the front and back of the eye. The results of this study will improve our understanding of the impact of the various treatments on the entire eye. The research will also ensure an improved understanding of the mechanisms of action of the various treatments and will provide insight of reasons for good or poor outcomes, based upon specific changes in structure and blood flow.
Read the detailed description
Diabetic Retinopathy (DR) is the single leading cause of blindness in people of working age. The total number of people living with diabetes in Canada is well over 2 million. The WHO estimates that around 12% of people with diabetes are blind or will develop severe vision loss. The two most common treatments of DR are: Laser Photocoagulation and anti-VEGF intravitreal injection. Clinical evidence demonstrates that these treatments lead to morphological and vascular retinal changes, however the actual mechanism and nature of post treatment changes is not fully understood. It is only recently that objective and quantitative imaging and hemodynamic technologies with previously unachievable resolution have become available that enable us to evaluate and to compare various effects of these treatments on vital eye structures.
We are proposing to take advantage of these state-of-the-art technologies in order to explore unknown effects of treatments on vital eye structures. We hypothesize that: 1) Laser Photocoagulation and anti-VEGF treatments will result in vessel constriction and hence reduction in posterior (retinal and choroidal) and anterior (conjunctival) ocular blood flow; 2) Changes in anterior segment ocular morphology and blood flow will positively correlate with changes in posterior segment morphology and blood flow; 3) Combined treatments will result in a greater reduction in posterior and anterior blood flow than any single treatment; 4) There will be differences in anterior and posterior blood flow outcomes and in anterior segment oxygen saturation when compared to healthy controls.
The study will include four groups of participants: Laser treatment group; Intravitreal injection of Bevacizumab treatment group; Intravitreal injection of Ranibizumab treatment group; Healthy age matched controls. The administration of ranibizumab and bevacizumab will be randomized across participants. Randomization number will be assigned to each participant and recorded in a Master Randomization Assignment List. All patients will be recruited from the Retina Clinics of the Toronto Western Hospital.
Every type 2 diabetic patient with Diabetic Macular Edema will be assessed prior to treatment and followed-up on the 3rd, 7th,30th day and 3 months after the initial treatment.
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes, Diabetic Macular Edema, Laser, Anti-VEGF, Morphology, Blood Flow, Vision
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Patients who are clinically indicated for the laser treatment | |
| Anti-VEGF Group (Bevacizumab) | Patients who are clinically indicated for the intravitreal injection of Bevacizumab | |
| Anti-VEGF Group (Ranibizumab) | Patients who are clinically indicated for intravitreal injection of Ranibizumab | |
| Age-matched controls | Group of non-diabetic participants who will be age and gender matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative inner retinal blood flow
Inner retinal blood flow will be measured using Canon Laser Blood Flowmeter
Measured: Baseline, 3, 7, 30 days and 3 months
Secondary outcomes (4)
Mean retinal thickness for an annulus centered on fovea
Mean retinal thickness will be measured using Heidelberg Spectralis Spectral Domain Optical Coherence Tomography
Measured: Baseline,3,7,30 days, and 3 months
Best Corrected Visual Acuity (LogMAR, EDTRS)
Best Corrected Visual Acuity will be examined using 96% and 10 % contrast EDTRS letter charts.
Measured: Baseline, 3, 7, 30 days and 3 months
Quantitative anterior blood flow
Quantitative anterior blood flow will be assessed by measuring velocity of individual rbc's (μm/sec) and blood oxygen saturation(%)
Measured: Baseline, 3, 7, 30 days and 3 months
Mean angle opening distance and trabecular-iris spur area
Mean angle opening distance and trabecular-iris spur area will be measured by Heidelberg Slit-Lamp Optical Coherence Tomography.
Measured: Baseline, 3, 7, 30 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Research Fund
- Responsible party
- Principal investigator, Chris Hudson, University of Toronto
- Investigators
- Christopher Hudson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196325
- Sponsor's protocol ID
- 09-0258-BE
- Acronym
- VEGF
- Status last verified
- Jan 2013
- First submitted
- 3 Sep 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy.
- ClinicalTrials.gov ID
- NCT01196325
- Acronym / sponsor ID
- VEGF / 09-0258-BE
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes, Diabetic Macular Edema, Laser, Anti-VEGF, Morphology, Blood Flow, Vision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Research Fund
- Study start
- Jul 2009
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 8 Sep 2010 (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.
The study will investigate changes in the structure and function of blood vessels in the front and back of the eye following laser and anti-VEGF treatments for sight-threatening diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control subjects and diabetic patients who require conventional or contemporary treatment for pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment using state-of-the-art techniques to measure vision, the rate of blood flow and structure at the front and back of the eye and the effectiveness of blood flow delivery. Changes following treatment in these novel, non-invasive techniques will be quantified and described. We anticipate that conventional and new / developing treatments will lead to narrowing of the vessels and consequent reduction of blood flow at the back and front of the eye. There will be a strong relationship between structural changes of the eye and functional changes of blood vessels at the front and back of the eye. The results of this study will improve our understanding of the impact of the various treatments on the entire eye. The research will also ensure an improved understanding of the mechanisms of action of the various treatments and will provide insight of reasons for good or poor outcomes, based upon specific changes in structure and blood flow.
Detailed description
Diabetic Retinopathy (DR) is the single leading cause of blindness in people of working age. The total number of people living with diabetes in Canada is well over 2 million. The WHO estimates that around 12% of people with diabetes are blind or will develop severe vision loss. The two most common treatments of DR are: Laser Photocoagulation and anti-VEGF intravitreal injection. Clinical evidence demonstrates that these treatments lead to morphological and vascular retinal changes, however the actual mechanism and nature of post treatment changes is not fully understood. It is only recently that objective and quantitative imaging and hemodynamic technologies with previously unachievable resolution have become available that enable us to evaluate and to compare various effects of these treatments on vital eye structures.
We are proposing to take advantage of these state-of-the-art technologies in order to explore unknown effects of treatments on vital eye structures. We hypothesize that: 1) Laser Photocoagulation and anti-VEGF treatments will result in vessel constriction and hence reduction in posterior (retinal and choroidal) and anterior (conjunctival) ocular blood flow; 2) Changes in anterior segment ocular morphology and blood flow will positively correlate with changes in posterior segment morphology and blood flow; 3) Combined treatments will result in a greater reduction in posterior and anterior blood flow than any single treatment; 4) There will be differences in anterior and posterior blood flow outcomes and in anterior segment oxygen saturation when compared to healthy controls.
The study will include four groups of participants: Laser treatment group; Intravitreal injection of Bevacizumab treatment group; Intravitreal injection of Ranibizumab treatment group; Healthy age matched controls. The administration of ranibizumab and bevacizumab will be randomized across participants. Randomization number will be assigned to each participant and recorded in a Master Randomization Assignment List. All patients will be recruited from the Retina Clinics of the Toronto Western Hospital.
Every type 2 diabetic patient with Diabetic Macular Edema will be assessed prior to treatment and followed-up on the 3rd, 7th,30th day and 3 months after the initial treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laser Group | – | –Patients who are clinically indicated for the laser treatment |
| Anti-VEGF Group (Bevacizumab) | – | –Patients who are clinically indicated for the intravitreal injection of Bevacizumab |
| Anti-VEGF Group (Ranibizumab) | – | –Patients who are clinically indicated for intravitreal injection of Ranibizumab |
| Age-matched controls | – | –Group of non-diabetic participants who will be age and gender matched |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients with clinically sight-threatening Diabetic Macular Edema will be recruited from the Retina Clinics of Toronto Western Hospital.
Key inclusion criteria (5 listed)
- Age range of 35-75 yrs
- Type 2 diabetes apart from age-matched control group
- Visual acuity of 20/400 or better
- Confirmed diagnose of Clinical Significant Diabetic Macular Edema (applies for Diabetic Groups only)
- Previously untreated eye for retinal diseases and disorders
Key exclusion criteria (11 listed)
- Distance refractive error > ± 6.00 DS \& / or ± 2.50 DC
- Intraocular pressure ≥ 22mm Hg
- Proliferative Diabetic Retinopathy
- Any other active eye disease and disorder
- Participants with history of cardiovascular events, stroke, thromboembolic events, transient ischemic attack, uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative inner retinal blood flow
Time frame: Baseline, 3, 7, 30 days and 3 months
Inner retinal blood flow will be measured using Canon Laser Blood Flowmeter
4 secondary outcomes
Mean retinal thickness for an annulus centered on fovea
Time frame: Baseline,3,7,30 days, and 3 months
Best Corrected Visual Acuity (LogMAR, EDTRS)
Time frame: Baseline, 3, 7, 30 days and 3 months
Quantitative anterior blood flow
Time frame: Baseline, 3, 7, 30 days and 3 months
Mean angle opening distance and trabecular-iris spur area
Time frame: Baseline, 3, 7, 30 days and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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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.
Christopher Hudson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by University of Toronto at 1 site in Canada.
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 5 inclusion and 11 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 24 Jan 2013. 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 Canada. 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 Olena Puzyeyeva, MD ((416)603-5694 ext. 5694, opuzyeye@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative inner retinal blood flow (time frame: Baseline, 3, 7, 30 days and 3 months). 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 24 Jan 2013.