OphthalmopathyPhase 2/3NCT04460001
Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)
A Phase 2/3 study testing Ranibizumab and triamcinolone acetate in people with Ophthalmopathy, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- Ranibizumab and triamcinolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 16 May 2019to 1 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
- A BCVA approximate Snellen equivalents, 20/40.
Who cannot join
- Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
- Pan-retinal laser photocoagulation 3 months or less before baseline,
- Topical ocular or systemic corticosteroids administered for 30 consecutive days.
- Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
- Use of intraocular corticosteroid implants,
- Uncontrolled glaucoma (intraocular pressure [IOP] 30 mmHg with medication) at the time of screening or baseline,
- iris neovascularization or neo-vascular glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO
- Conditions
- Ophthalmopathy
- Being tested
- Ranibizumab, triamcinolone acetate
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Intravitreal
RanibizumabDrug
Intravitreal
triamcinolone acetateDrug
intravitreal
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up Receives: Drug: Ranibizumab |
| Ranibizumab and triamcinolone acetate | Active comparator | intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up Receives: Drug: Ranibizumab; Drug: triamcinolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:
Best-Corrected Visual Acuity:
will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.
Measured: 2 year
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:
Optical Coherence Tomography:
will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start16 May 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460001
- Sponsor's protocol ID
- WAMohamed
- Status last verified
- Nov 2019
- First submitted
- 1 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT04460001
- Acronym / sponsor ID
- WAMohamed
- Conditions
- Ophthalmopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Jul 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.
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: Ranibizumabintravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up |
| Ranibizumab and triamcinolone acetate | Active comparator | Drug: Ranibizumab, Drug: triamcinolone acetateintravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
- A BCVA approximate Snellen equivalents, 20/40.
Key exclusion criteria (7 listed)
- Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
- Pan-retinal laser photocoagulation 3 months or less before baseline,
- Topical ocular or systemic corticosteroids administered for 30 consecutive days.
- Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
- Use of intraocular corticosteroid implants,
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 |
|---|---|---|
| RanibizumabIntravitreal | Drug | Ranibizumab |
| RanibizumabIntravitreal | Drug | Ranibizumab and triamcinolone acetate |
| triamcinolone acetateintravitreal | Drug | Ranibizumab and triamcinolone acetate |
Primary outcome
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
Time frame: 2 year
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Best-Corrected Visual Acuity: will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
Time frame: 2 year
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Optical Coherence Tomography: will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 Ranibizumab and triamcinolone acetate in people with Ophthalmopathy, run by Assiut University at 1 site in Egypt.
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 2 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 7 Jul 2020. 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 Egypt. 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 Wael Ismael (01006322380, wael.ali.ismael@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO (time frame: 2 year). The study lists 2 primary outcomes in all. 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 7 Jul 2020.