Age Related Macular DegenerationPhase 2/3NCT03609307
Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial
A Phase 2/3 study testing Combined Intravitreal bevacizumab and propranolol and Intravitreal bevacizumab in people with Age Related Macular Degeneration, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Combined Intravitreal bevacizumab and propranolol and Intravitreal bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Sep 2018to Feb 2019
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Wet AMD and Vision less than 20/40
Who cannot join
- History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),
- Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction
- History of ocular inflammation
- Subretinal fibrosis
- History of Cataract surgey less than 6 months
- History of Glaucoma Surgery ,Vitreoretinal surgery
- Media opacity
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Ramin Noorinia, MD, 009822591616, labbafi@hotmail.com
About this study
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.
Methods:
In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Combined Intravitreal bevacizumab and propranolol, Intravitreal bevacizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Intravitreal bevacizumab and propranololDrug
these patients receive two injections at each session Bavacizumab and propranolol
Intravitreal bevacizumabDrug
these patients receive only Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| injection Combined Intravitreal bevacizumab and propranolol | Active comparator | patients receive two injections at each session Bavacizumab Receives: Drug: Combined Intravitreal bevacizumab and propranolol |
| injection Intravitreal bevacizumab | Active comparator | patients receive only Bevacizumab Receives: Drug: Intravitreal bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Thickness
Spectral Domain Optical Coherence Tomography
Measured: 1 month
Secondary outcomes (1)
Visual acuity
Early Treatment Diabetic Retinopathy Study
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionFeb 2019 (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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 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
- NCT03609307
- Sponsor's protocol ID
- 96301
- Status last verified
- Jul 2018
- First submitted
- 25 Jul 2018
- Last updated
- 1 Aug 2018
- 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 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial
- ClinicalTrials.gov ID
- NCT03609307
- Acronym / sponsor ID
- 96301
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Aug 2018 (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.
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.
Methods:
In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injection Combined Intravitreal bevacizumab and propranolol | Active comparator | Drug: Combined Intravitreal bevacizumab and propranololpatients receive two injections at each session Bavacizumab |
| injection Intravitreal bevacizumab | Active comparator | Drug: Intravitreal bevacizumabpatients receive only Bevacizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Wet AMD and Vision less than 20/40
Key exclusion criteria (7 listed)
- History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),
- Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction
- History of ocular inflammation
- Subretinal fibrosis
- History of Cataract surgey less than 6 months
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 |
|---|---|---|
| Combined Intravitreal bevacizumab and propranololthese patients receive two injections at each session Bavacizumab and propranolol | Drug | injection Combined Intravitreal bevacizumab and propranolol |
| Intravitreal bevacizumabthese patients receive only Bevacizumab | Drug | injection Intravitreal bevacizumab |
Primary outcome
Macular Thickness
Time frame: 1 month
Spectral Domain Optical Coherence Tomography
1 secondary outcome
Visual acuity
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combined Intravitreal bevacizumab and propranolol and Intravitreal bevacizumab in people with Age Related Macular Degeneration, 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 7 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 1 Aug 2018. 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 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 Ramin Noorinia, 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?
Macular Thickness (time frame: 1 month). 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 1 Aug 2018.