Age-related Macular DegenerationEarly Phase 1NCT03571100
Comfort and Antimicrobial Efficacy of Chlorhexidine vs Betadine for Intravitreal Injections
A Early Phase 1 study testing Chlorhexidine and Povidine-Iodine in people with Age-related Macular Degeneration and Diabetic Vascular Diseases, run by MidAtlantic Retina at 1 site in United States.
Trial summary
The purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Diabetic Vascular Diseases, Proliferative Retinopathy
- What is being tested?
- Chlorhexidine and Povidine-Iodine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 6 May 2019
- Phase
- Early Phase 1
- 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
- Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
- Clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion.
- Age greater than 18.
Who cannot join
- Documented allergy to PI or AC
- Current diagnosis of infectious keratitis
- History of unilateral contact lens wear in the past 30 days
- Current unilateral use of prescription eye drops.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MidAtlantic Retina
Philadelphia, Pennsylvania, 19107
Michele Formoso, 215-928-3092, research@midatlanticretina.com
Devida Long, 215-928-3092, research@midatlanticretina.com
About this study
Official title: Patient Comfort and Antimicrobial Efficacy With Aqueous Chlorhexidine Versus Povidine-Iodine (Betadine) as Ocular Surface Disinfectant Prior to Intravitreal Injection
The purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection
Read the detailed description
This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). Patients will be recruited in the clinical offices of the Retina Service of Wills and Hospital/Mid Atlantic Retina clinic offices. Patients who are determined to require bilateral intravitreal injections of an anti-VEGF (vascular endothelial growth factor) agents by a retina specialist at their regularly scheduled retina appointment will be evaluated for qualification by study personnel. Patients who meet inclusion criteria will be identified and informed consent will be obtained. Prior to injection, topical anesthetic (0.5% proparacaine, Alcon) will be instilled in both eyes. Study personnel will obtain four samples from the superior and inferior fornices of the upper and lower lids of both eyes using swabs (COPAN ESwab, ThermoFisher Scientific) for patients enrolled at Wills. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% or AC 0.1% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. The injections will then be performed by the treating retina specialist. Following the injection, a second conjunctival culture will be taken in an identical manner to the first for patients enrolled at Wills. Study personnel will then instill fluorescein dye (fluorescein sodium ophthalmic, BioGlo) into each eye, and a brief slit lamp examination will be performed. Study personnel will record surface findings according to the Ocular Surface Score and a numerical score for each eye will be determined. On post-injection day one study personnel will call the patient and ask to rate the pain in each eye using the same verbal numerical rating scale. No additional clinic visits will be required as part of the study.
- Conditions
- Age-related Macular Degeneration, Diabetic Vascular Diseases, Proliferative Retinopathy, Retina Vein Occlusion
- Being tested
- Chlorhexidine, Povidine-Iodine
- Medical subject headings
- Macular Degeneration, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called Aqueous chlorhexidine
Chlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine)
Povidine-IodineDrug
Also called Betadine
Povidine iodine administration prior to intravitreal injection (compared to chlorhexidine)
| Study group | Role | What they receive |
|---|---|---|
| Povidine-Iodine | Active comparator | Bilateral injections patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye Receives: Drug: Povidine-Iodine |
| Chlorhexidine | Active comparator | Bilateral injections patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Comfort
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
Measured: One day following injection
Secondary outcomes (2)
Culture of conjunctiva for bacteria
Microbial flora
Measured: 7 days
Patient Comfort
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
Measured: I minute after drop instilled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start7 May 2018
- Primary completion6 May 2019 (estimated)
- Study completion6 May 2019 (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 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MidAtlantic Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Sunir Garg, MD, Principal investigator, MidAtlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571100
- Sponsor's protocol ID
- 18-692E
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali FS, Jenkins TL, Boparai RS, Obeid A, Ryan ME, Wibblesman TD, Chiang A, Garg SJ; Post-Injection Endophthalmitis Study Group. Aqueous Chlorhexidine Compared with Povidone-Iodine as Ocular Antisepsis before Intravitreal Injection: A Randomized Clinical Trial. Ophthalmol Retina. 2021 Aug;5(8):788-796. doi: 10.1016/j.oret.2020.11.008. Epub 2020 Nov 20.
PubMed 33221515
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Comfort and Antimicrobial Efficacy With Aqueous Chlorhexidine Versus Povidine-Iodine (Betadine) as Ocular Surface Disinfectant Prior to Intravitreal Injection
- ClinicalTrials.gov ID
- NCT03571100
- Acronym / sponsor ID
- 18-692E
- Conditions
- Age-related Macular Degeneration, Diabetic Vascular Diseases, Proliferative Retinopathy, Retina Vein Occlusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MidAtlantic RetinaUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 6 May 2019 (estimated)
- Study completion
- 6 May 2019 (estimated)
- First posted
- 27 Jun 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 purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection
Detailed description
This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). Patients will be recruited in the clinical offices of the Retina Service of Wills and Hospital/Mid Atlantic Retina clinic offices. Patients who are determined to require bilateral intravitreal injections of an anti-VEGF (vascular endothelial growth factor) agents by a retina specialist at their regularly scheduled retina appointment will be evaluated for qualification by study personnel. Patients who meet inclusion criteria will be identified and informed consent will be obtained. Prior to injection, topical anesthetic (0.5% proparacaine, Alcon) will be instilled in both eyes. Study personnel will obtain four samples from the superior and inferior fornices of the upper and lower lids of both eyes using swabs (COPAN ESwab, ThermoFisher Scientific) for patients enrolled at Wills. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% or AC 0.1% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. The injections will then be performed by the treating retina specialist. Following the injection, a second conjunctival culture will be taken in an identical manner to the first for patients enrolled at Wills. Study personnel will then instill fluorescein dye (fluorescein sodium ophthalmic, BioGlo) into each eye, and a brief slit lamp examination will be performed. Study personnel will record surface findings according to the Ocular Surface Score and a numerical score for each eye will be determined. On post-injection day one study personnel will call the patient and ask to rate the pain in each eye using the same verbal numerical rating scale. No additional clinic visits will be required as part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized prospective trial
| Arm | Type | Receives |
|---|---|---|
| Povidine-Iodine | Active comparator | Drug: Povidine-IodineBilateral injections patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye |
| Chlorhexidine | Active comparator | Drug: ChlorhexidineBilateral injections patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
- Clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion.
- Age greater than 18.
Key exclusion criteria (4 listed)
- Documented allergy to PI or AC
- Current diagnosis of infectious keratitis
- History of unilateral contact lens wear in the past 30 days
- Current unilateral use of prescription eye drops.
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 |
|---|---|---|
| ChlorhexidineAlso: Aqueous chlorhexidineChlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine) | Drug | Chlorhexidine |
| Povidine-IodineAlso: BetadinePovidine iodine administration prior to intravitreal injection (compared to chlorhexidine) | Drug | Povidine-Iodine |
Primary outcome
Patient Comfort
Time frame: One day following injection
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
2 secondary outcomes
Culture of conjunctiva for bacteria
Time frame: 7 days
Patient Comfort
Time frame: I minute after drop instilled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Derived from this study: PubMed 33221515Ali FS, Jenkins TL, Boparai RS, Obeid A, Ryan ME, Wibblesman TD, Chiang A, Garg SJ; Post-Injection Endophthalmitis Study Group. Aqueous Chlorhexidine Compared with Povidone-Iodine as Ocular Antisepsis before Intravitreal Injection: A Randomized Clinical Trial. Ophthalmol Retina. 2021 Aug;5(8):788-796. doi: 10.1016/j.oret.2020.11.008. Epub 2020 Nov 20.
- Individual participant dataSharing planned: No
Related trials for Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
Sunir Garg, MD principal investigator
MidAtlantic Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chlorhexidine and Povidine-Iodine in people with Age-related Macular Degeneration and Diabetic Vascular Diseases, run by MidAtlantic Retina at 1 site in United States.
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 4 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 27 Jun 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Michele Formoso (215-928-3092, research@midatlanticretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comfort (time frame: One day following injection). 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 NCT03571100, 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 27 Jun 2018.