<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02206789</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2011011CLI</org_study_id>
    <nct_id>NCT02206789</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection</brief_title>
  <official_title>Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aravind Eye Care System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aravind Eye Care System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the&#xD;
      efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk&#xD;
      characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in&#xD;
      preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials &amp;&#xD;
      Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom&#xD;
      satisfactorily meet The inclusion criteria are different for each study Eligible candidates&#xD;
      will be enrolled after signing an Informed Consent form Patients will be randomized into one&#xD;
      of 2 groups&#xD;
&#xD;
        -  Only on topical steroids group A&#xD;
&#xD;
        -  On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized&#xD;
           non-blinded study at a single centre. Methodology In both arms&#xD;
&#xD;
           1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2&#xD;
           weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1&#xD;
           year is completed Systemic steroids may be administered in the initial 2 weeks at the&#xD;
           discretion of the investigators. (For all patients with fungal keratitis topical&#xD;
           steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until&#xD;
           then voveran ophtha may be used&#xD;
&#xD;
           3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day&#xD;
           for 2years&#xD;
&#xD;
           4. All patients will be followed for a minimum period of 2 years&#xD;
&#xD;
           5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3&#xD;
           months until 2 years are completed&#xD;
&#xD;
           6. All episodes of graft rejection will be treated as per accepted norms and the patient&#xD;
           will no longer follow the standardized protocol for steroid administration&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>graft rejection</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>recovery from graft rejection</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of graft rejection in patients maintained only on cyclosporine after 1year</measure>
    <time_frame>5 years</time_frame>
    <description>.graft rejection in patients only on cyclosporine 2% eye drops in the second year of study</description>
  </secondary_outcome>
  <other_outcome>
    <measure>incidence of glaucoma and cataract.</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Corneal Graft Rejection</condition>
  <arm_group>
    <arm_group_label>penetrating keratoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years&#xD;
.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>therapeutic keratoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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&#xD;
.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone acetate1%,</intervention_name>
    <description>efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection</description>
    <arm_group_label>penetrating keratoplasty</arm_group_label>
    <arm_group_label>therapeutic keratoplasty</arm_group_label>
    <other_name>pred forte (Prednisolone acetate1% )</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone acetate1%, cyclosporine 2%</intervention_name>
    <description>penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection</description>
    <arm_group_label>penetrating keratoplasty</arm_group_label>
    <arm_group_label>therapeutic keratoplasty</arm_group_label>
    <other_name>pred forte (Prednisolone acetate1% )</other_name>
    <other_name>aurosporine (cyclosporine 2%)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FOR ARM 1&#xD;
&#xD;
        Age greater than 18 years&#xD;
&#xD;
        Vision more than 6/60 in the fellow eye.&#xD;
&#xD;
        No prior keratoplasty&#xD;
&#xD;
        Not more than 1 quadrant of corneal vascularisation&#xD;
&#xD;
        No peripheral anterior synechiae.&#xD;
&#xD;
        No active ocular surface disease (VKC, dry eye,)&#xD;
&#xD;
        Uncontrolled uveitis or glaucoma&#xD;
&#xD;
        No limbal stem cell failure.&#xD;
&#xD;
        No Prior h/o HSV&#xD;
&#xD;
        Primarily patients with dystrophies, degenerations and pseudophakic bullous keratopathy and&#xD;
        non vascularised non herpetic corneal scars will be enrolled&#xD;
&#xD;
        ARM 2:&#xD;
&#xD;
        Inclusion criteria as above &amp;&#xD;
&#xD;
        Those patients with medically unresponsive keratitis with no limbal involvement and in whom&#xD;
        the graft size can be restricted to less than 9mm will be included in the study. This is to&#xD;
        ensure that postoperative issues such as synechiae, recurrence of infection and&#xD;
        uncontrolled glaucoma do not affect the study. Grafts must also be clear at the end of one&#xD;
        month after surgery for patients to continue in the study..&#xD;
&#xD;
        Expected Outcome&#xD;
&#xD;
          1. Incidence of graft rejection in both arms.&#xD;
&#xD;
          2. secondary outcome Recovery from graft rejection in both arms.&#xD;
&#xD;
          3. Secondary outcomes- incidence of glaucoma and cataract.&#xD;
&#xD;
          4. secondary outcome Incidence of graft rejection in patients maintained only on&#xD;
             cyclosporine after 1year.&#xD;
&#xD;
          5. It is expected that patients receiving cyclosporine will have a lesser incidence of&#xD;
             graft rejection and exhibit faster recovery. The efficacy of long term prophylaxis of&#xD;
             only cyclosporine in preventing graft rejection will also be evaluated.&#xD;
&#xD;
        Exclusion Criteria:Any condition that would increase the risk of non-rejection graft&#xD;
        failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.&#xD;
        Schirmer's test ≤ 5 mm in 1 minute Clinical evidence of limbal stem cell deficiency History&#xD;
        of or active herpes simplex virus keratitis or other acute corneal infection&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.Anita Raghavan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Cornea Consultant</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>dr.anita raghavan</last_name>
    <phone>04224360400</phone>
    <phone_ext>407</phone_ext>
    <email>annieram2001@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dr.Anita Raghavan</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641014</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr.Anita Raghavan</last_name>
      <phone>04224360400</phone>
      <phone_ext>407</phone_ext>
      <email>annieram2001@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Dr.Anita Raghavan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr.Revathi Rajaraman</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr.Mangala Periyasamy</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2011</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Cyclosporins</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02206789
org study id: IRB2011011CLI
nct id: NCT02206789
lead sponsor: 
has dmc: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: graft rejection
time frame: 5 years
measure: recovery from graft rejection
time frame: 5 years
measure: Incidence of graft rejection in patients maintained only on cyclosporine after 1year
time frame: 5 years
description: .graft rejection in patients only on cyclosporine 2% eye drops in the second year of study
measure: incidence of glaucoma and cataract.
time frame: 5 years
arm group label: penetrating keratoplasty
arm group type: Active Comparator
description: 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
.
arm group label: therapeutic keratoplasty
arm group type: Active Comparator
description: 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
.
intervention type: Drug
intervention name: Prednisolone acetate1%,
description: efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
arm group label: penetrating keratoplasty
arm group label: therapeutic keratoplasty
other name: pred forte (Prednisolone acetate1% )
intervention type: Drug
intervention name: Prednisolone acetate1%, cyclosporine 2%
description: penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
arm group label: penetrating keratoplasty
arm group label: therapeutic keratoplasty
other name: pred forte (Prednisolone acetate1% )
other name: aurosporine (cyclosporine 2%)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dr.Anita Raghavan
role: Principal Investigator
affiliation: Medical Cornea Consultant
last name: dr.anita raghavan
phone: 04224360400
phone ext: 407
email: annieram2001@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: India
responsible party type: Sponsor
mesh term: Cyclosporine
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Cyclosporins
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate