Diabetic Macular EdemaPhase 2pain & visualNCT02790775
Pain and Visual Outcome in Intravitreal Bevacizumab Injection
A Phase 2 study testing Anti-VEGF in quadrant 1, Anti-VEGF in quadrant 2 and Anti-VEGF in quadrant 3 in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Anti-VEGF in quadrant 1, Anti-VEGF in quadrant 2 and Anti-VEGF in quadrant 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 1 siteIran
- Study dates
- Dec 2015to 30 Aug 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions
Who cannot join
- history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.
- Conditions
- Diabetic Macular Edema
- Being tested
- Anti-VEGF in quadrant 1, Anti-VEGF in quadrant 2, Anti-VEGF in quadrant 3, Anti-VEGF in quadrant 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF in quadrant 1Drug
Anti-VEGF in quadrant 2Drug
Anti-VEGF in quadrant 3Drug
Anti-VEGF in quadrant 4Drug
| Study group | Role | What they receive |
|---|---|---|
| Injection Anti-VEGF in quadrant 1 | Active comparator | Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1 Receives: Drug: Anti-VEGF in quadrant 1 |
| Injection Anti-VEGF in quadrant 2 | Active comparator | Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2 Receives: Drug: Anti-VEGF in quadrant 2 |
| InjectionAnti-VEGF in quadrant 3 | Active comparator | Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3 Receives: Drug: Anti-VEGF in quadrant 3 |
| InjectionAnti-VEGF in quadrant 4 | Active comparator | Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4 Receives: Drug: Anti-VEGF in quadrant 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analog Scale (VAS)
Measured: immediately after Intravitreal Bevacizumab Injection
Secondary outcomes (1)
Best-corrected visual acuity (BCVA)
using Snellen chart
Measured: preoperative and 1 month postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startDec 2015
- Primary completion30 May 2016
- Study completion30 Aug 2016
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790775
- Sponsor's protocol ID
- 94312
- Acronym
- pain & visual
- Status last verified
- Sep 2015
- First submitted
- 1 Jun 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
- ClinicalTrials.gov ID
- NCT02790775
- Acronym / sponsor ID
- pain & visual / 94312
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 Aug 2016
- First posted
- 6 Jun 2016 (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.
In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Injection Anti-VEGF in quadrant 1 | Active comparator | Drug: Anti-VEGF in quadrant 1Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1 |
| Injection Anti-VEGF in quadrant 2 | Active comparator | Drug: Anti-VEGF in quadrant 2Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2 |
| InjectionAnti-VEGF in quadrant 3 | Active comparator | Drug: Anti-VEGF in quadrant 3Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3 |
| InjectionAnti-VEGF in quadrant 4 | Active comparator | Drug: Anti-VEGF in quadrant 4Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions
Key exclusion criteria (1 listed)
- history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)
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 |
|---|---|---|
| Anti-VEGF in quadrant 1 | Drug | Injection Anti-VEGF in quadrant 1 |
| Anti-VEGF in quadrant 2 | Drug | Injection Anti-VEGF in quadrant 2 |
| Anti-VEGF in quadrant 3 | Drug | InjectionAnti-VEGF in quadrant 3 |
| Anti-VEGF in quadrant 4 | Drug | InjectionAnti-VEGF in quadrant 4 |
Primary outcome
Pain
Time frame: immediately after Intravitreal Bevacizumab Injection
Visual Analog Scale (VAS)
1 secondary outcome
Best-corrected visual acuity (BCVA)
Time frame: preoperative and 1 month postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-VEGF in quadrant 1, Anti-VEGF in quadrant 2 and Anti-VEGF in quadrant 3 in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 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: finished, as of the sponsor's last update on 30 Aug 2017. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: immediately after Intravitreal Bevacizumab Injection). 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 30 Aug 2017.