Corneal Graft RejectionNCT02206789
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection
A study testing Prednisolone acetate1%, and Prednisolone acetate1%, cyclosporine 2% in people with Corneal Graft Rejection, run by Aravind Eye Care System at 1 site in India.
Trial summary
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study 1 (PKP study) B. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Graft Rejection
- What is being tested?
- Prednisolone acetate1%, and Prednisolone acetate1%, cyclosporine 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2012to Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FOR ARM 1
- Age greater than 18 years
- Vision more than 6/60 in the fellow eye.
- No prior keratoplasty
- Not more than 1 quadrant of corneal vascularisation
- No peripheral anterior synechiae.
Show all 21Show fewer
- No active ocular surface disease (VKC, dry eye,)
- Uncontrolled uveitis or glaucoma
- No limbal stem cell failure.
- No Prior h/o HSV
- Primarily patients with dystrophies, degenerations and pseudophakic bullous keratopathy and non vascularised non herpetic corneal scars will be enrolled
- ARM 2:
- Those patients with medically unresponsive keratitis with no limbal involvement and in whom the graft size can be restricted to less than 9mm will be included in the study. This is to ensure that postoperative issues such as synechiae, recurrence of infection and uncontrolled glaucoma do not affect the study. Grafts must also be clear at the end of one month after surgery for patients to continue in the study..
- Expected Outcome
- Incidence of graft rejection in both arms.
- secondary outcome Recovery from graft rejection in both arms.
- Secondary outcomes- incidence of glaucoma and cataract.
- secondary outcome Incidence of graft rejection in patients maintained only on cyclosporine after 1year.
- It is expected that patients receiving cyclosporine will have a lesser incidence of graft rejection and exhibit faster recovery. The efficacy of long term prophylaxis of only cyclosporine in preventing graft rejection will also be evaluated.
- Exclusion Criteria:Any condition that would increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis. Schirmer's test ≤ 5 mm in 1 minute Clinical evidence of limbal stem cell deficiency History of or active herpes simplex virus keratitis or other acute corneal infection
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr.Anita Raghavan
Coimbatore, Tamil Nadu, 641014
Dr.Anita Raghavan, 04224360400 ext. 407, annieram2001@yahoo.com
Dr.Anita Raghavan
About this study
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials \& Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom satisfactorily meet The inclusion criteria are different for each study Eligible candidates will be enrolled after signing an Informed Consent form Patients will be randomized into one of 2 groups
- Only on topical steroids group A
- On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized non-blinded study at a single centre. Methodology In both arms
- Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until then voveran ophtha may be used
- Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years
- All patients will be followed for a minimum period of 2 years
- Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed
- All episodes of graft rejection will be treated as per accepted norms and the patient will no longer follow the standardized protocol for steroid administration
- Conditions
- Corneal Graft Rejection
- Being tested
- Prednisolone acetate1%,, Prednisolone acetate1%, cyclosporine 2%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone acetate1%,Drug
Also called pred forte (Prednisolone acetate1% )
efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
Prednisolone acetate1%, cyclosporine 2%Drug
Also called pred forte (Prednisolone acetate1% ), aurosporine (cyclosporine 2%)
penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
| Study group | Role | What they receive |
|---|---|---|
| penetrating keratoplasty | Active comparator | each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators.
3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years
. Receives: Drug: Prednisolone acetate1%,; Drug: Prednisolone acetate1%, cyclosporine 2% |
| therapeutic keratoplasty | Active comparator | each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids will be administered only after 2 weeks post keratoplasty.) Until then diclofenac sodium0.1% may be used 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years
. Receives: Drug: Prednisolone acetate1%,; Drug: Prednisolone acetate1%, cyclosporine 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft rejection
Measured: 5 years
Secondary outcomes (2)
recovery from graft rejection
Measured: 5 years
Incidence of graft rejection in patients maintained only on cyclosporine after 1year
.graft rejection in patients only on cyclosporine 2% eye drops in the second year of study
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startFeb 2012
- Primary completionFeb 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Graft RejectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aravind Eye Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Anita Raghavan, Principal investigator, Medical Cornea Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206789
- Sponsor's protocol ID
- IRB2011011CLI
- Status last verified
- Oct 2011
- First submitted
- 31 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection
- ClinicalTrials.gov ID
- NCT02206789
- Acronym / sponsor ID
- IRB2011011CLI
- Conditions
- Corneal Graft Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aravind Eye Care SystemUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- 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.
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials \& Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom satisfactorily meet The inclusion criteria are different for each study Eligible candidates will be enrolled after signing an Informed Consent form Patients will be randomized into one of 2 groups
- Only on topical steroids group A
- On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized non-blinded study at a single centre. Methodology In both arms
- Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until then voveran ophtha may be used
- Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years
- All patients will be followed for a minimum period of 2 years
- Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed
- All episodes of graft rejection will be treated as per accepted norms and the patient will no longer follow the standardized protocol for steroid administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| penetrating keratoplasty | Active comparator | Drug: Prednisolone acetate1%,, Drug: Prednisolone acetate1%, cyclosporine 2%each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years . |
| therapeutic keratoplasty | Active comparator | Drug: Prednisolone acetate1%,, Drug: Prednisolone acetate1%, cyclosporine 2%each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids will be administered only after 2 weeks post keratoplasty.) Until then diclofenac sodium0.1% may be used 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- FOR ARM 1
- Age greater than 18 years
- Vision more than 6/60 in the fellow eye.
- No prior keratoplasty
- Not more than 1 quadrant of corneal vascularisation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prednisolone acetate1%,Also: pred forte (Prednisolone acetate1% )efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection | Drug | penetrating keratoplasty, therapeutic keratoplasty |
| Prednisolone acetate1%, cyclosporine 2%Also: pred forte (Prednisolone acetate1% ), aurosporine (cyclosporine 2%)penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection | Drug | penetrating keratoplasty, therapeutic keratoplasty |
Primary outcome
graft rejection
Time frame: 5 years
2 secondary outcomes
recovery from graft rejection
Time frame: 5 years
Incidence of graft rejection in patients maintained only on cyclosporine after 1year
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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.
Dr.Anita Raghavan principal investigator
Medical Cornea Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone acetate1%, and Prednisolone acetate1%, cyclosporine 2% in people with Corneal Graft Rejection, run by Aravind Eye Care System at 1 site in India.
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 21 inclusion and 0 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 2014. 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 India. 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.
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 dr.anita raghavan (04224360400 ext. 407, annieram2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft rejection (time frame: 5 years). 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 2014.