Diabetic Macular EdemaPhase 4NCT03458923
Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
A Phase 4 study testing Diclofenac Sodium 0.1 ml containing 500µg and Ranibizumab 0.5 mg Solution for Injection in people with Diabetic Macular Edema, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Diclofenac Sodium 0.1 ml containing 500µg and Ranibizumab 0.5 mg Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Jun 2018
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
- Diabetes Mellitus type one and two
- Best Corrected Visual Acuity > 0.1 LogMar
Who cannot join
- Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
- Patients with a history of branch or central retinal artery occlusion
- Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
- Visual Significant Cataract
- Evidence of vitreomacular traction or macular ischemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mohamed S El Agha, PhD, 00201001638180, mselagha@hotmail.com
About this study
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.
Read the detailed description
Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B.
Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity.
Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
Group B will undergo intravitreal injection of 0.5 mg Ranibizumab, repeated monthly for 3 months. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
All patients will be examined weekly for one month and then monthly for three months after the injection. At every visit, visual acuity, intraocular pressure, and a dilated fundus examination will be performed.
All patients will be required to instill topical antibiotic Gatifloxacin postoperatively 3 times per day for 5 days.
Patients will be warned about the signs and symptoms of complications (endophthalmitis, retinal detachment, vitreous hemorrhage, lens trauma) and asked to seek medical attention immediately.
- Conditions
- Diabetic Macular Edema
- Being tested
- Diclofenac Sodium 0.1 ml containing 500µg, Ranibizumab 0.5 mg Solution for Injection
- Keywords
- Diclofenac, Ranibizumab, Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Sodium 0.1 ml containing 500µgDrug
Also called nonsteroidal anti-inflammatory drug
15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
Ranibizumab 0.5 mg Solution for InjectionDrug
Also called anti vascular endothelial growth factor
15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months. Receives: Drug: Diclofenac Sodium 0.1 ml containing 500µg |
| Group B | Active comparator | 15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months. Receives: Drug: Ranibizumab 0.5 mg Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best corrected visual acuity
Measuring the best corrected visual acuity
Measured: 3 months of follow up
Change in central macular thickness
Measuring the change in central macular thickness using Optical Coherence Tomography
Measured: 3 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iyad Adnan Salem Goussous, Cairo University
- Investigators
- Mohamed S El Agha, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458923
- Sponsor's protocol ID
- Iyad Goussous
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 8 Mar 2018
- 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 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
- ClinicalTrials.gov ID
- NCT03458923
- Acronym / sponsor ID
- Iyad Goussous
- Conditions
- Diabetic Macular Edema
- Keywords
- Diclofenac, Ranibizumab, Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Mar 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.
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.
Detailed description
Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B.
Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity.
Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
Group B will undergo intravitreal injection of 0.5 mg Ranibizumab, repeated monthly for 3 months. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
All patients will be examined weekly for one month and then monthly for three months after the injection. At every visit, visual acuity, intraocular pressure, and a dilated fundus examination will be performed.
All patients will be required to instill topical antibiotic Gatifloxacin postoperatively 3 times per day for 5 days.
Patients will be warned about the signs and symptoms of complications (endophthalmitis, retinal detachment, vitreous hemorrhage, lens trauma) and asked to seek medical attention immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Diclofenac Sodium 0.1 ml containing 500µg15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months. |
| Group B | Active comparator | Drug: Ranibizumab 0.5 mg Solution for Injection15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
- Diabetes Mellitus type one and two
- Best Corrected Visual Acuity > 0.1 LogMar
Key exclusion criteria (5 listed)
- Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
- Patients with a history of branch or central retinal artery occlusion
- Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
- Visual Significant Cataract
- Evidence of vitreomacular traction or macular ischemia
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 |
|---|---|---|
| Diclofenac Sodium 0.1 ml containing 500µgAlso: nonsteroidal anti-inflammatory drug15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months | Drug | Group A |
| Ranibizumab 0.5 mg Solution for InjectionAlso: anti vascular endothelial growth factor15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months | Drug | Group B |
Primary outcome
Change in best corrected visual acuity
Time frame: 3 months of follow up
Measuring the best corrected visual acuity
Change in central macular thickness
Time frame: 3 months of follow up
Measuring the change in central macular thickness using Optical Coherence Tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- 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.
Mohamed S El Agha, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac Sodium 0.1 ml containing 500µg and Ranibizumab 0.5 mg Solution for Injection in people with Diabetic Macular Edema, run by Cairo 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 3 inclusion and 5 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 8 Mar 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 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Iyad A Goussous, MSc (00201062453343, dr.iyad.goussous@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best corrected visual acuity (time frame: 3 months of follow up). 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 8 Mar 2018.