Non-proliferative Diabetic RetinopathyPhase 2/3NCT04511715
Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy
A Phase 2/3 study testing Intravitreal Bevacizumab IVB and Follow-up with regular examination for determination of DR progression in people with Non-proliferative Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences.
Trial summary
In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy
- What is being tested?
- Intravitreal Bevacizumab IVB and Follow-up with regular examination for determination of DR progression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Nov 2021
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
- Diagnosis of DM (type 1 or 2) with age more than 18 years' old
- Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart
Who cannot join
- Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
- History of retinal laser photocoagulation
- Tractional retinal detachment involving the macula
- Evidence of neovascularization of angle on examination
- Macular edema due to a cause other than DME
- Any ocular condition which may change visual acuity during the study
Show all 10Show fewer
- History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months
- History of any use of intravitreal corticosteroid
- History of major intra-ocular surgery except cataract surgery in the past 6 months
- History of thromboembolic every in the past 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
- Conditions
- Non-proliferative Diabetic Retinopathy
- Being tested
- Intravitreal Bevacizumab IVB, Follow-up with regular examination for determination of DR progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Bevacizumab IVBDrug
Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
Follow-up with regular examination for determination of DR progressionOther
regular examination for determination of DR progression
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Bevacizumab IVB group | Active comparator | Not described Receives: Drug: Intravitreal Bevacizumab IVB |
| undergo regular follow-up for Diabetic Retinopathy | Sham comparator | Not described Receives: Other: Follow-up with regular examination for determination of DR progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups
Measured: 12 months
Secondary outcomes (3)
Best corrected visual acuity
Best corrected visual acuity based on ETDRS letter scale and logMAR
Measured: 12 months
Central retinal thickness
Central retinal thickness according to macular ocular coherence tomography
Measured: 12 months
Number of visits
Number of visits in each time point
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic RetinopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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
- NCT04511715
- Sponsor's protocol ID
- 9800
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04511715
- Acronym / sponsor ID
- 9800
- Conditions
- Non-proliferative Diabetic Retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 13 Aug 2020 (actual)
- 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 randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Bevacizumab IVB group | Active comparator | Drug: Intravitreal Bevacizumab IVB |
| undergo regular follow-up for Diabetic Retinopathy | Sham comparator | Other: Follow-up with regular examination for determination of DR progression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
- Diagnosis of DM (type 1 or 2) with age more than 18 years' old
- Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart
Key exclusion criteria (10 listed)
- Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
- History of retinal laser photocoagulation
- Tractional retinal detachment involving the macula
- Evidence of neovascularization of angle on examination
- Macular edema due to a cause other than DME
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 Bevacizumab IVBIntravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment | Drug | Intravitreal Bevacizumab IVB group |
| Follow-up with regular examination for determination of DR progressionregular examination for determination of DR progression | Other | undergo regular follow-up for Diabetic Retinopathy |
Primary outcome
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
Time frame: 12 months
Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups
3 secondary outcomes
Best corrected visual acuity
Time frame: 12 months
Central retinal thickness
Time frame: 12 months
Number of visits
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravitreal Bevacizumab IVB and Follow-up with regular examination for determination of DR progression in people with Non-proliferative Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences.
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 3 inclusion and 10 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Homayon Nikkhah, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging (time frame: 12 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 13 Aug 2020.