Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection

NCT ID: NCT02206789

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-12-31

Brief 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. 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

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 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

3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years

4. All patients will be followed for a minimum period of 2 years

5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed

6. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

penetrating keratoplasty

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

.

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate1%,

Intervention Type: DRUG

efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Prednisolone acetate1%, cyclosporine 2%

Intervention Type: DRUG

penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

therapeutic keratoplasty

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

.

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate1%,

Intervention Type: DRUG

efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Prednisolone acetate1%, cyclosporine 2%

Intervention Type: DRUG

penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Interventions

Prednisolone acetate1%,

efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Intervention Type: DRUG

Prednisolone acetate1%, cyclosporine 2%

penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Intervention Type: DRUG

Other Intervention Names

pred forte (Prednisolone acetate1% ); pred forte (Prednisolone acetate1% ); aurosporine (cyclosporine 2%)

Eligibility Criteria

Inclusion Criteria

• 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.

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

1. Incidence of graft rejection in both arms.

2. secondary outcome Recovery from graft rejection in both arms.

3. Secondary outcomes- incidence of glaucoma and cataract.

4. secondary outcome Incidence of graft rejection in patients maintained only on cyclosporine after 1year.

5. 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aravind Eye Care System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Anita Raghavan

Role: PRINCIPAL_INVESTIGATOR

Medical Cornea Consultant

Locations

Dr.Anita Raghavan

Coimbatore, Tamil Nadu, India

Site Status: RECRUITING

Countries

India

Central Contacts

dr.anita raghavan

Role: CONTACT

annieram2001@yahoo.com

04224360400 ext. 407

Facility Contacts

Dr.Anita Raghavan

Role: primary

annieram2001@yahoo.com

04224360400 ext. 407

Other Identifiers

IRB2011011CLI

Identifier Type: -

Identifier Source: org_study_id