Proliferative Diabetic RetinopathyPhase 2NCT04800679
Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR
A Phase 2 study testing receive 4 monthly IVB injections and then rescue IVB, PRP group and IVB injections and a modified laser in people with Proliferative Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- receive 4 monthly IVB injections and then rescue IVB, PRP group and IVB injections and a modified laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2020to Dec 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of PDR with the indication of full PRP according the intend of investigator
- Best corrected visual acuity of 20/320 or better
- Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT
Who cannot join
- History of prior PRP with more than 100 burns outside the posterior pole
- Tractional retinal detachment involving the macula
- Evidence of neoplasia of angle on examination
- Macular edema due to a cause other than DME
- Any ocular condition which may change visual acuity during the study
- Substantial cataract which has declined the vision by 3 lines or more
Show all 11Show fewer
- History of intravitreal injection of anti-VEGF agent in past 2 months
- History of any use of corticosteroid during past 4 months
- History of major intra-ocular surgery except cataract surgery
- History of YAG laser capsulotomy during past 2 months
- Aphakia and uncontrolled glaucoma according to investigator judgment
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Ali reza Ramezani, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: Combination Therapy for PDR
In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- receive 4 monthly IVB injections and then rescue IVB, PRP group, IVB injections and a modified laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receive 4 monthly IVB injections and then rescue IVBDrug
IVB group that receive 4 monthly IVB injections and then rescue IVB
PRP groupDrug
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
IVB injections and a modified laserDrug
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
| Study group | Role | What they receive |
|---|---|---|
| intravitreal bevacizumab injections and then rescue | Active comparator | Not described Receives: Drug: receive 4 monthly IVB injections and then rescue IVB |
| PRP group | Active comparator | Not described Receives: Drug: PRP group |
| IVB injections and a modified laser | Active comparator | Not described Receives: Drug: IVB injections and a modified laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
Number of neovascular tissue counted by investigator according to FAG
Measured: 12 months
Secondary outcomes (2)
Best corrected visual acuity based on Snellen chart
Measured: 12 months
Central retinal thickness according to macular OCT
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 posted16 Mar 2021
- Study start1 Mar 2020
- Primary completion1 Jul 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 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
- NCT04800679
- Sponsor's protocol ID
- 97378
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.
PubMed 35594075
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy for PDR
- ClinicalTrials.gov ID
- NCT04800679
- Acronym / sponsor ID
- 97378
- Conditions
- Proliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Mar 2021 (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 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and 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, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravitreal bevacizumab injections and then rescue | Active comparator | Drug: receive 4 monthly IVB injections and then rescue IVB |
| PRP group | Active comparator | Drug: PRP group |
| IVB injections and a modified laser | Active comparator | Drug: IVB injections and a modified laser |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of PDR with the indication of full PRP according the intend of investigator
- Best corrected visual acuity of 20/320 or better
- Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT
Key exclusion criteria (11 listed)
- History of prior PRP with more than 100 burns outside the posterior pole
- Tractional retinal detachment involving the macula
- Evidence of neoplasia of angle on examination
- Macular edema due to a cause other than DME
- Any ocular condition which may change visual acuity during the study
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 |
|---|---|---|
| receive 4 monthly IVB injections and then rescue IVBIVB group that receive 4 monthly IVB injections and then rescue IVB | Drug | intravitreal bevacizumab injections and then rescue |
| PRP groupPRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB | Drug | PRP group |
| IVB injections and a modified laserCombination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser | Drug | IVB injections and a modified laser |
Primary outcome
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
Time frame: 12 months
Number of neovascular tissue counted by investigator according to FAG
2 secondary outcomes
Best corrected visual acuity based on Snellen chart
Time frame: 12 months
Central retinal thickness according to macular OCT
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 16 Mar 2021.
- Derived from this study: PubMed 35594075Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.
Related trials for Proliferative Diabetic Retinopathy
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
RecruitingObservational study
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Diabetic Retinopathy, Diabetes Mellitus, Type 2
Not yet recruitingPhase 4
Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
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.
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 receive 4 monthly IVB injections and then rescue IVB, PRP group and IVB injections and a modified laser in people with Proliferative Diabetic Retinopathy, 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 3 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 16 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Ramezani, 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?
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800679, which also lists 1 linked publication.
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 Mar 2021.