## Protocol Section
### Identification Module
**NCT ID:** NCT04800679

**Brief Title:** Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR

**Official Title:** Combination Therapy for PDR

#### Organization Study ID Info
**ID:** 97378
#### Organization
**Class:** OTHER
**Full Name:** Shahid Beheshti University of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2021-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-03-16

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-13

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-01

**Type:** ACTUAL

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2021-03-16
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-28
**Study First Submit QC Date:** 2021-03-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shahid Beheshti University of Medical Sciences

#### Responsible Party

**Investigator Affiliation:** Shahid Beheshti University of Medical Sciences

**Investigator Full Name:** Zahra Rabbani Khah

**Investigator Title:** Head of ophthalmic research center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.

### Conditions Module

**Conditions:**

- Proliferative Diabetic Retinopathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 105

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: receive 4 monthly IVB injections and then rescue IVB

**Label:** intravitreal bevacizumab injections and then rescue

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: PRP group

**Label:** PRP group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Drug: IVB injections and a modified laser

**Label:** IVB injections and a modified laser

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intravitreal bevacizumab injections and then rescue

**Description:** IVB group that receive 4 monthly IVB injections and then rescue IVB

**Name:** receive 4 monthly IVB injections and then rescue IVB

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- PRP group

**Description:** PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB

**Name:** PRP group

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- IVB injections and a modified laser

**Description:** Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

**Name:** IVB injections and a modified laser

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of neovascular tissue counted by investigator according to FAG

**Measure:** Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** Best corrected visual acuity based on Snellen chart

**Time Frame:** 12 months

**Measure:** Central retinal thickness according to macular OCT

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Presence of PDR with the indication of full PRP according the intend of investigator
* Best corrected visual acuity of 20/320 or better
* Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT

Exclusion Criteria:

* History of prior PRP with more than 100 burns outside the posterior pole
* Tractional retinal detachment involving the macula
* Evidence of neoplasia of angle on examination
* Macular edema due to a cause other than DME
* Any ocular condition which may change visual acuity during the study
* Substantial cataract which has declined the vision by 3 lines or more
* History of intravitreal injection of anti-VEGF agent in past 2 months
* History of any use of corticosteroid during past 4 months
* History of major intra-ocular surgery except cataract surgery
* History of YAG laser capsulotomy during past 2 months
* Aphakia and uncontrolled glaucoma according to investigator judgment

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** labbafi@hotmail.com

**Name:** Alireza Ramezani, MD

**Phone:** 009822591616

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tehran

**Contacts:**

***Contact 1:***

- **Email:** labbafi@hotmail.com

- **Name:** Ali reza Ramezani, MD

- **Phone:** 009822591616

- **Role:** CONTACT

**Country:** Iran, Islamic Republic of

**Facility:** Ophthalmic Research Center

**Status:** RECRUITING

### References Module

#### References

**Citation:** Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.

**PMID:** 35594075

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M7125

- Name: Diabetic Retinopathy

- Relevance: HIGH

- As Found: Diabetic Retinopathy

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003930

- Term: Diabetic Retinopathy

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M246

- Name: Bevacizumab

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
